The Drugs and Cosmetics Act, 1940 (the "DC Act") and the Drugs and Cosmetic Rules, 1945 (the "DC Rules") regulate the manufacturing, importation, sale and distribution of pharmaceuticals in India.

The Medical Device Rules, 2017 (the "MD Rules") under the DC Act along with the DC Rules regulate the importation, manufacture, sale and distribution of the following:

• substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, and blood and blood component collection bags with or without anticoagulants covered under the DC Act;
• substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under the DC Act; and
• medical devices notified under the DC Act (notified medical devices).

The New Drugs and Clinical Trials Rules, 2019 (the "CT Rules") under the DC Act regulate clinical trials, bio-equivalence studies, bio-availability studies and the Ethics Committee (EC) for new drugs and investigational new drugs for human use.

The Narcotic Drugs and Psychotropic Substances Act, 1985 (the "NDPS Act") prohibits a person from producing/manufacturing/cultivating, possessing, selling, purchasing, transporting, storing and/or consuming any narcotic drug or psychotropic substance.

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (the "DMR Act") regulates the advertisement of pharmaceuticals in India. It prohibits advertisements of drugs and remedies that claim to have magical properties.

The Medicinal and Toilet Preparations (Excise Duties) Act, 1956 provides for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, and narcotic drug or narcotic.

The Essential Commodities Act, 1955 and the Drugs (Prices Control) Order 2013 (DPCO) thereunder regulate the price of drugs and medical devices specified in the National List of Essential Medicines (NLEM).

The Rules for the manufacture, use, import, export and storage of hazardous micro-organisms/genetically engineered organisms or cells, 1989, notified under the Environment (Protection) Act, 1986 (the "1989 Rules").

In addition to the above, there are specific guidelines for various issues; for example, the conduct of clinical trials, market authorisation of biosimilars, ribosomal DNA (rDNA) research, ethics and privacy of healthcare-related data.

Regulatory Bodies/Committees/Authorities

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for drugs and medical devices. The CDSCO works under the Directorate General of Health Services (DGHS) of the Ministry of Health and Family Welfare of India (MoHFW). It is headed by the Drugs Controller General of India (DCGI). The DCGI or the Joint Drugs Controller or the Deputy Drugs Controller appointed by the central government under the DC Act constitute the “Central Licensing Authority” (CLA).

The CDSCO is advised by two statutory committees, the Drug Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC). The DTAB advises the central government and the state governments on technical matters and the DCC secures uniform implementation of the DC Act.

The notified body under the MD Rules is responsible for carrying out the audits of the manufacturing sites of Class A and Class B medical devices to verify conformity with the Quality Management System. The National Accreditation Body (NAB) under the MD Rules lays down the standards and conformity assessment activities for the accreditation of the notified body.

The Narcotics Control Bureau regulates and implements the provisions of the NDPS Act.

The National Pharmaceutical Pricing Authority (NPPA) is responsible for monitoring, fixing and revising the prices of drugs and medical devices, and enforcement of the provisions of the DPCO.

The Indian Council of Medical Research (ICMR) is the apex body for the formulation, co-ordination and promotion of biomedical research.

All the above regulatory bodies operate under various ministries of the government of India.

Any person who is aggrieved by any order passed by the CLA (for example, cancellation, suspension or rejection of the application) may file an appeal to the central government, within the stipulated period. The central government may make orders in relation to the appeal after an inquiry into the matter considered necessary and after giving the appellant an opportunity for making a representation in the matter.

An appeal can be filed against any order of a regulatory authority according to the process laid down under the relevant legislation or regulation.

There are different categories of pharmaceuticals and medical devices, which are regulated differently. The DC Rules provide for the classification of drugs in various schedules. Each schedule has a guideline for labelling, storing, selling, displaying and prescribing a listed drug. The schedules are as follows:

• Schedule C – a list of biological and immunological products, antibiotics, ophthalmic preparations and all products for parenteral use;
• Schedule C(I) – a list of drugs of biological origin, namely alkaloids, hormones, vitamins and antibiotics for oral use;
• Schedule G – a list of drugs that can be administered only under the supervision of a registered medical practitioner;
• Schedule H – a list of drugs that are required to be dispensed on the prescription of a registered medical practitioner;
• Schedule H1 – a list of drugs including antibiotics, habit-forming drugs and a few anti-tuberculosis medicines; and
• Schedule X – a list of psychotropic drugs that are required to be dispensed on the prescription of a registered medical practitioner. A special retail licence is required for selling these drugs.

Similarly, the MD Rules provide for a risk-based classification of all medical devices as follows:

• Class A – low-risk equipment; for example, absorbent cotton wools, surgical dressings, alcohol swabs;
• Class B – low to moderate-risk equipment; for example, thermometers, blood pressure monitoring devices, disinfectants;
• Class C – moderate to high-risk equipment; for example, implants, haemodialysis catheters; and
• Class D – high-risk equipment; for example, angiographic guidewires, heart valves.

The CDSCO regulates the clinical trials of drugs and medical devices. The CLA is entrusted with the task of granting permission for clinical trials and regulates the sale and importation of drugs and medical devices for use in the clinical trials. A clinical trial is required to be conducted in accordance with the Good Clinical Practices (GCP) Guidelines issued by the CDSCO.

The CT Rules regulate the clinical trials, bio-equivalence studies, bio-availability studies and investigations into new drugs for human use. The DC Rules regulate clinical trials for veterinary drugs.

The MD Rules regulate the clinical investigation of medical devices and the clinical performance evaluations of new in vitro diagnostic medical devices. The EC for clinical investigations of medical devices is constituted in accordance with the DC Rules.

The National Guidelines for Gene Therapy Product Development and Clinical trials, 2019 (the "GTP guidelines") provide guidance for conducting clinical trials in areas pertaining to gene therapy.

The National Ethical Guidelines for Biomedical and Health research involving human participants, 2019, and the National Ethical Guidelines for Biomedical Research involving Children (collectively, the "Ethical Guidelines") provide general guidance for ethically conducting clinical trials involving adults and children.

In order to obtain market authorisation for any of the following, one is required to conduct detailed clinical trials, or investigations or performance studies, as the case may be.

• New drug – a "new drug" is considered "new" for a period of four years from the date of its first approval and can be any of the following:
1. a drug that has not been used in India to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof, and has not been recognised as effective and safe by the CLA for the proposed claims; also, the limited use, if any, has been with the permission of the CLA;
2. a drug already approved by the CLA for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained-release dosage form) and route of administration;
3. a fixed-dose combination of two or more drugs individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, namely indications dosage, dosage form (including sustained-release dosage form) and route of administration;
4. biologics, including the biosimilars; or
5. a modified or sustained-release form of a drug or a novel drug delivery system of any drug approved by the CLA.
• Investigational new drug – a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.
• Investigational medical device – a device that does not have its predicate device or a device that after being authorised for marketing, claims for the new intended use or new population, or new material or a major design change.
• New in vitro diagnostic medical device – any in vitro diagnostic medical device covered under the MD Rules that has not been approved for manufacture for sale or for importation by the CLA and is being tested to establish its performance for the relevant analyte or other parameter related thereto, including details of the technology and procedure required.

An application for conducting a clinical trial can be filed in a prescribed format with all the necessary documents and information before the CLA via SUGAM, an online licensing portal. The CLA is required to evaluate the application within the prescribed time. An application for drugs discovered, researched and manufactured in India is required to be evaluated within 30 days. If the CLA does not respond within 30 days to the application for drugs developed in India, the applicant may conclude that the permission to conduct the trial has been granted.

The clinical trial can be initiated only after the approval of the trial protocol and other related documents by the EC. The EC for a particular trial site reviews and accords approval to the clinical trial, bio-availability or bio-equivalence protocol, and the related documents and forwards its report to the CLA. If the EC rejects the protocol, the details of the same should be submitted to the CLA before seeking approval of another EC for conducting the clinical trial at the same site. The CLA is informed about the approval granted by the EC within the stipulated time of the grant of such approval. After scrutiny of the information and documents furnished with the application, the CLA may either grant permission to conduct the clinical trial or reject the application for the reasons to be recorded in writing. The permission to initiate a clinical trial remains valid for a period of two years from the date of its grant.

The MD Rules discuss two types of clinical investigations: a pilot study and a pivotal study. A pilot study is an exploratory study that is used to acquire specific essential information about a medical device before beginning the pivotal clinical investigation. A pivotal study is a confirmatory study to support the safety and effectiveness evaluation of the medical device for its intended use. For an investigational medical device developed in India, the applicant is required to conduct both pilot and pivotal studies in India.

Waiver of the Requirement for a Local Clinical Trial in Certain Cases of New or Investigational Drugs

The CLA, with approval from the central government, may waive the requirement for a local clinical trial for the approval of a new drug already approved in other countries in the following cases.

• The new drug is approved and marketed in countries specified under the CT Rules, and no unexpected serious adverse events have been reported, and:
1. there is no probability or evidence, on the basis of existing knowledge, of difference in the Indian population of the enzymes or gene involved in the metabolism of the new drug or any factor affecting the pharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and
2. the applicant has given an undertaking in writing to conduct a Phase IV clinical trial to establish the safety and effectiveness of such new drug as per the design approved by the CLA.
• For the importation of a new drug for which the CLA had already granted permission to conduct a global clinical trial, which is ongoing in India, and in the meantime this new drug has been approved for marketing in a country specified under the CT Rules, and:
1. there is no probability or evidence, on the basis of existing knowledge, of difference in the Indian population of the enzymes or gene involved in the metabolism of the new drug or any factor affecting the pharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and
2. the applicant has given an undertaking in writing to conduct a Phase IV clinical trial to establish the safety and effectiveness of such new drug as per the design approved by the CLA.

Further, the requirements may be relaxed, abbreviated, omitted or deferred in the case of life-threatening or serious disease conditions, or rare diseases, and for drugs intended to be used in diseases of special relevance to the Indian scenario or for an unmet medical need in India, a disaster or a special defence use.

The CLA may relax the requirement of local Phase IV clinical trials where the new drug is indicated in life-threatening or serious diseases, or diseases of special relevance to the Indian health scenario or for a condition that has an unmet need in India, for rare diseases for which drugs are not available or available at a high cost, or if it is an orphan drug.

Waiver of the Requirement of Pivotal Studies in Certain Cases of New or Investigational Medical Devices

A pivotal clinical study is not required to be conducted for investigational medical devices classified under class A of the MD Rules. However, in exceptional cases, the CLA, may, for reasons to be recorded in writing, mandate conducting a pivotal clinical study of such devices as well, depending on the nature of the medical device.

For investigational medical devices developed and studied in a country other than India, the applicant is required to submit the details of the pilot clinical investigation or relevant clinical study data generated outside India along with the application. The CLA may grant permission to either repeat a pilot study or to conduct a pivotal clinical investigation only.

The clinical investigation may not be required in the case of investigation medical devices approved for at least two years in the USA, the UK, Australia, Canada or Japan, if certain conditions are met.

It is mandatory to register clinical trials prospectively in the ICMR-Clinical Trials Registry India (ICMR-CTRI), which is a free, online platform.

Trials registered on the ICMR-CTRI are publicly available and free to search.

The Ethical Guidelines set out the principle of ensuring the privacy and confidentiality of the participants of the clinical trials.

Further, the CT Rules and the MD Rules require the investigator of a clinical trial to give an undertaking that they will maintain the confidentiality of the identities of all the participants and ensure the security of the clinical trial data.

This is not applicable in this jurisdiction.

The DC Act and the MD Rules provide definitions of a "drug" and a "medical device" respectively. Only products that fall within these definitions are regulated.

Until recently, 37 categories of medical devices were notified or regulated as drugs.

However, on 11 February 2020, the MoFHW expanded the definition of a medical device via a notification. With the new definition coming into effect from April 2020, the MD Rules now apply to all medical devices except for the devices in Annexure A (“New Devices”). Annexure A contains the list of medical devices that have been specifically notified thus far.

Owing to the special nature of biologics, there are specific requirements that need to be fulfilled to obtain marketing authorisation for them.

All types of biologics, including biosimilars, are considered as "new drugs" under the DC rules. Therefore, an application for obtaining market authorisation is required to be submitted with detailed clinical trial data for all types of biologics.

The applicant is required to conduct the following studies in respect of all types of biologics:

• pre-clinical studies;
• clinical studies; and
• post-market surveillance.

In addition, comparative data of the pre-clinical studies and clinical studies of biosimilars and reference biologics are required to be submitted for a biosimilar.

In addition to the DC Act, the DC Rules and other general guidelines and regulations mentioned above, the following regulations and guidelines are specifically relevant for the approval of biologics:

• the 1989 Rules;
• the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016 (the "Similar Biologics Guidelines"), which lay down the regulatory pathway for a similar biologic;
• the Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017 (the "rDNA Research Guidelines"), which provide guidance on handling hazardous biological material, recombinant nucleic acid molecules and cells, organisms, and viruses containing such molecules;
• the GTP guidelines, which aim to guide and enable the stakeholders to comprehend and comply with the regulatory requirements for research and development of gene therapy products in India; it also provides basic guidance for research involving human participants, including clinical trials, pertaining to the broad area of gene therapy;
• the Guidance Document for Industry: Submission of Stability Data and Related Documents for Review and Expert Opinion for Granting Post-approval Changes in Shelf Life of Recombinant Biotherapeutic Products and Therapeutic Monoclonal Antibodies, published by the National Institute of Biologicals 2016 (the "Post-Approval Guidelines"), which provide recommendations to holders of marketing authorisations for recombinant technology-based products, who intend to make post-approval changes in the shelf life of such product in accordance with CDSCO guidance Document No – PAC/1108 Version – 1.1; and
• the Guidelines and Handbook for Institutional Biosafety Committee (IBSC).

In addition to the CDSCO, the approval of biologics is overseen by the following:

• the Review Committee on Genetic Manipulation (RCGM) – the RCGM is responsible for authorising the conduct of research and development, the exchange of genetically engineered cell banks for the purpose of research and development, and the review of data up to pre-clinical evaluation;
• the Institutional Biosafety Committee (IBSC) – the IBSC is required to be constituted by any person (including research institutions) handling hazardous microorganisms and/or genetically engineered organisms, and is responsible for ensuring biosafety on-site, along with an initial review of applications to be recommended to the RCGM; the IBSC is also assigned with the responsibility to review and authorise firms for the exchange of aforesaid organisms for the purpose of research; and
• the Genetic Engineering Appraisal Committee (GEAC) – the GEAC reviews applications and approves activities where the final drug product contains genetically modified organisms/living modified organisms.

An original licence or a renewed licence for the manufacture for sale or distribution of drugs, unless suspended or cancelled, is valid for five years from the date on which it is granted or renewed. If the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of an additional fee, the licence continues to be in force until orders are passed on the application. The licence is deemed to have expired if an application for its renewal is not made within six months after its expiry.

An importation licence for a drug, unless suspended or cancelled, remains valid for a period of three years from the date of its issue. If an application for a fresh licence is made three months before the expiry of the existing licence, the current licence is deemed to continue in force until orders are passed on the application.

The licence for manufacture, distribution, sale, importation and exportation of the medical devices granted under the MD Rules remains valid unless suspended, cancelled or surrendered. The licensee is required to pay a prescribed fee every five years to prevent the cancellation of the licence. If the licence is cancelled due to non-payment of the fee within the stipulated time, the licensee has to apply for a fresh licence.

If the licensee fails to comply with any of the stipulated conditions prescribed under the regulations, the CLA may suspend or cancel the licence by an order in writing, stating the reasons, after giving an opportunity to show cause why such an order not be passed.

On 11 February 2020, the MoHFW introduced a new definition of a medical device (see 3.1 Product Classification: Pharmaceutical or Medical Devices). On the same day, the MoHFW issued another notification requiring the registration of such newly notified medical devices on the online portal of the CDSCO according to the timeline specified therein.

An application for market authorisation of a drug or a medical device may be filed electronically via SUGAM in the prescribed format with the prescribed fee. For a new drug or an investigational new drug/medical device, or a new in vitro diagnostic medical device, the application must be accompanied by detailed clinical trial data. For other types of drugs, the application must be accompanied by bio-equivalence and bio-availability studies.

An already approved drug or medical device with modified or new claims or a fixed-dose combination is treated as a new drug or an investigational medical device, respectively. In such cases, the application is required to be submitted with detailed clinical data.

The DC Act and the DC Rules provide for limited access to drugs or medical devices, the importation of which is, otherwise, not allowed.

Small quantities of a new drug or investigational medical device may be imported for the treatment of patients suffering from life-threatening diseases, or diseases causing serious permanent disability, or a disease requiring therapies for unmet medical needs, by a medical officer of a government hospital or an autonomous medical institution providing tertiary care, duly certified by the medical superintendent of the government hospital, or head of the autonomous medical institution, subject to specific conditions.

Small quantities of a drug or a medical device, the importation of which is otherwise prohibited, may be imported for personal use subject to specific conditions. Further, the importation of small quantities of a drug or a medical device donated to a charitable hospital for the treatment of patients free of cost may be allowed by the CLA.

On 5 June 2020, the central government, in consultation with the DTAB, issued a draft New Drugs and Clinical Trials (Amendment) Rules, 2020 for compassionate use of any new unapproved drug. The draft rules allow application for the importation of an unapproved new drug for compassionate use for the treatment of patients by hospitals and medical institutions.

The holder of the marketing authorisation for a new drug, an investigational new drug or a medical device is under the obligation to conduct post-market surveillance (PMS) or Phase IV clinical trials. The holder is required to submit a periodic safety update report (PSUR). The CLA may extend the total duration of a submission of the PSUR if it is considered necessary in the interest of public health. The PSUR data is then reviewed by the CLA in consultation with an expert committee. Based on the analysis of the expert committee, a decision is taken by the CLA on the safety and efficacy of the drug or medical device. The data emerging through the PSUR or any other PMS studies forms the basis of further decisions about indications/usage/restrictions on indications of the drug or the medical device and a further decision on the extension of the duration of submission of the PSUR data.

Third parties cannot access any information regarding pending applications for marketing authorisations for drugs and medical devices.

Adulterated, misbranded, spurious or illegally distributed drugs and medical devices are regulated under the DC Act, the DC Rules and the MD Rules, as the case may be. The manufacture for sale or for distribution, selling, stocking, exhibiting or offering for sale or distribution of such drugs and medical devices is a penal offence punishable with imprisonment and/or a fine of a varying degree based on the seriousness of the offence.

The Customs Act, 1960 (the "Customs Act"), along with the Intellectual Property Rights (Imported Goods) and the Enforcement Amendment Rules, 2018 (the "IPREA Rules"), prohibits the importation of goods that infringe on intellectual property (except patents). The Customs Act empowers the customs authority to confiscate goods subject to the conditions and procedures specified under the IPREA Rules. The owner of the IP right (IPR) is required to record their IPR at the Indian Customs IPR Recordation Portal. The owner also has to sign a bond with the customs authority undertaking to pay the costs of retention/destruction of the infringing goods and to indemnify the customs office for damages incurred during the retention/destruction.

Further, customs can, on its own initiative, suspend the clearance of the imported goods if there is prima facie evidence or reasonable grounds to believe that the goods are infringing IPRs. In such a scenario, the rights-holder or its agent will have to comply with the requirements of the recordal within five days, else the goods may be released.

The manufacturing plants of drugs and medical devices are subjected to an authorisation. The CDSCO is the main regulatory body for granting the authorisation.

The DC Rules lay down the requirement of factory premises, plant and equipment for manufacturing depending on the type or schedule of drug or the type of medical device. The MD Rules also stipulate a Quality Management System that a manufacturer is required to use.

An application for authorisation of a manufacturing plant may be filed via SUGAM. Separate applications are required to be filed for separate premises. On the receipt of the application, the State Licensing Authority (SLA) inspects the manufacturing site. If the SLA is satisfied, a report is prepared and forwarded to the CLA. On receipt of the documents, an inspection of the manufacturing site is carried out by an inspector (appointed by the CLA) and an expert in the concerned field. If the CLA is satisfied, authorisation is granted to the applicant.

For Class A medical devices, a licence is granted within the prescribed time without an audit of the manufacturing site. However, the manufacturing site is audited by a registered notified body after the grant of the licence. The licence remains valid if a licence retention fee is paid, before expiry, every five years from the date of its issue unless it is suspended or cancelled by the licensing authority.

The manufacturer of the new medical devices is required to obtain a registration number under the MD Rules for manufacturing of medical devices (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceutical or Medical Devices).

Establishments engaged in the wholesale of drugs and medical devices are subject to authorisation by the SLA.

An application for obtaining a wholesale licence to sell, stock, exhibit or offer for sale or distribute a drug or a medical device may be filed via SUGAM. The licence is issued based on the category of the drug or medical device in question.

A licence issued remains valid if the licensee deposits a licence retention fee, before expiry, every five years from the date of its issue unless it is suspended or cancelled by the licensing authority.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The DC Act, the DC Rules and the Customs Act, 1962 (the "Customs Act") regulate the importation and exportation of drugs in India. The importation and exportation of medical devices are regulated by the MD Rules along with the DC Act and the Customs Act. The CDSCO and customs are the main regulatory bodies for implementing these pieces of legislation and regulations. The CLA grants the licence for importation or exportation.

There are no specific requirements or qualifications required for a person to act as an importer of record.

The importation of drugs and medical devices in India is subject to prior authorisations from the CLA. Limited access to unauthorised drugs and medical devices is allowed in specific circumstances with specific conditions; see 3.5 Access to Pharmaceutical and Medical Devices without Marketing Authorisations.

The importer of the new medical device is required to obtain a registration number under the MD rules for importing medical devices (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceutical or Medical Devices).

The importation of drugs and medical devices into India is regulated by the CDSCO under the DC Act, the DC Rules and the MD Rules, as the case may be. Any drug or medical device for which an importation licence must be prescribed cannot be imported without one. The DC Act, the DC Rules and the MD Rules lay down the procedure for obtaining the importation licence and standards of quality that must be met for imported drugs and medical devices. Thus, the importation of drugs and medical devices that are not of standard quality or are misbranded, adulterated or spurious is prohibited under the DC Act.

The DC Act and the MD Rules also stipulate labelling requirements for imported drugs and medical devices. For example, the importation of the following is prohibited:

• any patented or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it, together with the quantities thereof; and
• any drug that, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed.

Further, the central government has powers to prohibit the importation of drugs and medical devices in the name of public interest.

India is not a member of any trade bloc or party to a free trade agreement.

The DPCO controls the price of drugs and medical devices listed in the National List of Essential medicines (NLEM) ("listed drugs and medical devices"). The NLEM is updated from time to time based on the recommendation of the MoHFW. The NPPA is the regulatory body that regulates and monitors the price of drugs and medical devices in India.

The DPCO provides a formula for calculating the ceiling price and the maximum retail price (MRP) of the listed drugs and medical devices. In extraordinary circumstances, the government may fix the ceiling price or the retail price of any drug or medical device in the public interest. Also, if the ceiling price or the retail price of the drug is already fixed and notified, the government may allow an increase or decrease in the same.

The DPCO sets out conditions that the manufacturers, dealers and distributors are required to follow for listed drugs and medical devices. Further, the DPCO stipulates that the government monitors the MRP of all drugs and medical devices, including non-listed drugs and medical devices, and ensures that no manufacturer increases the MRP of a drug by more than 10% of the MRP during the preceding 12 months.

According to the NPPA Policy, 2012, the following are kept out of any drug control:

• a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (the "Patents Act") and not produced elsewhere, if developed through R&D in India ("indigenous R&D"), is eligible for exemption from price control in respect of that drug for five years from the date of commencement of its commercial production in the country;
• a manufacturer producing a drug in the country by a new process developed through indigenous R&D and patented under the Patents Act would be eligible for exemption from price control in respect of that drug for a period of five years from the date of commencement of its commercial production in the country; and
• a formulation involving a new delivery system developed through indigenous R&D would be eligible for exemption from price control for five years from the date of its market approval in India.

According to the NPPA Policy, 2012, the key principles for the regulation of a drug price are:

• the essentiality of drugs;
• the control of formulation prices only; and
• market-based pricing.

The DPCO provides that, at least initially, the source of market-based data will be the data available with the pharmaceuticals market data specialising company IMS Health and if the government deems it necessary, it may validate such data by appropriate survey or evaluation.

The government funds and operates several healthcare/insurance schemes for reimbursement of the costs of pharmaceuticals and medical devices for people of weaker economic sections and government employees; for example, Ayushman Bharat and the Central Government Health Scheme.

The government has created an institutional arrangement called the Health Technology Assessment in India (HTAIn) under the Department of Health Research (DHR). HTAIn is responsible for collating and, where needed, generating evidence related to the clinical effectiveness, cost effectiveness and safety of medicines, devices and health programmes using the health technology assessment (HTA) approach. The objective of this arrangement is to facilitate the process of transparent and evidence-informed decision-making in the field of health. However, the arrangement is still at a very nascent stage and not fully functional.

The Indian National Cost database under the arrangement aims to provide a one-stop shop for cost information for healthcare decision-making in India. The database is intended for a diverse set of users, including health economists involved in economic evaluation, healthcare programme managers establishing budgets, policymakers making resource allocation decisions, Ministry of Health personnel setting prices, health financing experts looking at resource requirements, researchers, consultants, non-governmental organisations and donors.

The prescription of drugs by a physician or a medical practitioner is regulated by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (amended 2016) (the "IMC Regulations"), which stipulate that:

• a physician shall write his name and designation in full along with registration particulars in his prescription letterhead;
• every physician should prescribe drugs with generic names legibly and preferably in capital letters, and they shall ensure a rational prescription and use of drugs;
• the attending physician may prescribe medicine at any time for the patient, whereas the consultant may prescribe only in the case of an emergency or as an expert when called for; and
• the prescription should also make clear if the physician himself dispensed any medicine.

Further, the DC Rules stipulate that the prescription must be in writing, and signed and dated.

The Pharmacy Act, 1948 prohibits a person other than a registered pharmacist from the compounding, preparing, mixing or dispensing of any medicine prescribed by a medical practitioner.

The Telemedicine Practice Guidelines (TPG) issued on 25 March 2020 provide guidelines for technology platforms such as mobile apps and websites enabling telemedicine.

According to the new definition of a medical device, any software or app used with an instrument or an article for diagnosis, prevention or monitoring of diseases/disorders may be classified as a medical device (please see 3.1 Product Classification: Pharmaceutical or Medical Devices).

The TPG serve as an aid and a tool to enable registered medical practitioners (RMPs) to effectively leverage telemedicine. The TPG also cover norms and standards of the RMP to consult patients via telemedicine. The TPG require telemedicine to be appropriate and sufficient as per context. They also require the identification of the RMP and the patient. Further, it is a must to obtain the patient’s consent. It is also incumbent on the RMP to maintain the records/documents for the period as prescribed from time to time.

An RMP can provide medical attention through a mobile device.

There are no special rules for the promotion and/or advertising of medicines and medical devices through online portals, company web pages and social networks. The DC Rules and the DMR Act regulate the advertisement of drugs and medical devices in India in general.

The Advertising Standards Council of India (ASCI) – a non-profit organisation comprising media, advertising agencies and advertisers – has published a code regulating the publishing of advertisements in India, which applies to advertisements relating to drugs as well.

The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) issued by the Department of Pharmaceuticals also has directions on what promotional materials for drugs should contain.

Electronic prescriptions are regulated and allowed in India.

According to the TPG, RMPs providing teleconsultation can send an e-prescription or a digital copy of a signed prescription to the patient via email or any messaging platform. It entails the same professional accountability as a traditional in-person consultation. There are certain limitations on prescribing medicines on consultation via telemedicine depending upon the type of consultation and mode of consultation.

The TPG provide categories of medicines that can be prescribed via telemedicine that are notified from time to time.

Pharmacies can dispense prescription drugs only on the production of a valid prescription.

Under the Information Technology Act, 2000 (the "IT Act"), where the law requires a document to be signed, it would be deemed to be legal only if digitally signed. This would imply that merely uploading a scanned copy of a prescription may not be recognised as valid under the law.

There are currently no specific rules that govern online sales of drugs and medical devices.

However, the Union Health Ministry of India has issued draft E-pharmacy Rules for regulating the sale of drugs by e-pharmacies. The Rules are expected to come into force in the near future.

On 26 March 2020, due to COVID-19, the MoHFW allowed the retail sale of drugs by a licensee to the doorstep of consumers against prescriptions received by email to meet the requirements arising because of the pandemic.

The Electronic Health Record Standards for India, 2016 (EHRS), issued by the MoHFW, provide for standardisation and homogeneity, and inter-operability in the capture, storage, transmission and use of healthcare information across various health IT systems.

The IT Act, the Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011 (the "Data Protection Rules") and the Information Technology (Intermediaries Guidelines) Rules, 2011 govern the protection of data. The definition of "sensitive personal data or information" (SPDI) of a person under the Data Protection Rules includes a physical, physiological or mental health condition and their medical records and history. On 24 August 2017, a nine-judge bench of the Supreme Court ruled that the right to privacy is a fundamental right for Indian citizens under Article 21 of the Indian Constitution.

The Data Protection Rules provide guidelines that need to be followed by a body corporate while collecting, storing and transferring the information. Obtaining consent from the person providing the information is one of the important requirements of the Data Protection Rules. It is also important to ensure that the person providing the information is aware that the information is being collected, its purpose and intended recipients, as well as the names and addresses of the agencies collecting and retaining the information. The body corporate or any person on its behalf holding SPDI shall not retain that information for longer than is required for the purposes for which the information may lawfully be used or is otherwise required under any other law for the time being in force. The disclosure of SPDI by the body corporate to any third party requires prior consent from the provider of such information.

In August 2020, the National Digital Health Mission (NDHM) was launched by the central government. The objective of the NDHM is to digitise India’s healthcare ecosystem. It also aims to provide a health ID to all medical practitioners, clinical establishments and patients.

Under the NDHM, the MoHFW drafted the Health Data Management Policy (HDMP), which has been made open to the public for comments.

Among other things, the HDMP provides the framework for the creation of health IDs. Under the HDMP, the patient has complete ownership over the health data. It also provides a framework on the utilisation of this data.

Patents are regulated in India under the Patents Act, 1990 and the Patents Rules, 2003 (the "Patents Rules"). The most common issue encountered by patent applicants is patentability of the subject matter for which a patent is sought. Apart from being novel, inventive and useful, the subject matter must not fall within a list of inventions specifically excluded from patentability. Specific exclusions with respect to pharmaceuticals and medical devices are:

• an invention that could be contrary to public order or morality;
• any living thing or non-living substance occurring in nature;
• mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance;
• the mere discovery of any new property or new use for a known substance;
• a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;
• mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way;
• any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products;
• plants and animals in whole or any part thereof; and
• traditional knowledge.

Second and subsequent medical uses of a known product are not patentable in India. Use, per se, is not patentable in India.

There are no mechanisms for patent term extension for drugs in India.

The following acts when performed with the consent of the patentee constitute an infringement of a patent:

• making, using, offering for sale, selling or importing for those purposes a patented product in India; and
• using a patented process, and using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India.

The Patents Act provides for the following defences to patent infringement:

• use of a patented invention on foreign vessels or aircraft temporarily or accidentally within the territory of India;
• making, constructing, using, selling or importing a patented invention solely for use reasonably related to the development and submission of information required under any law that regulates the manufacture, construction, use, sale or importation of any product in India or any other country;
• importation of patented products by any person from a person who is duly authorised under law to produce and sell or distribute the product;
• importation or manufacture of a patented product or a product made by a patented process by or on behalf of the government for its own use;
• use or manufacture of a patented product or a product made by a patent process or use of a patent process merely for experimentation or research, or for imparting instructions to pupils; and
• importation of the patented medicine or patented drug by the government for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the government or any other dispensary, hospital or other medical institution that the central government, having regard to the public service, specifies by notification in the Official Gazette.

Further, in any suit for infringement of a patent, every ground on which it may be revoked is available as a ground for defence.

Compulsory Licences

The Patents Act provides for a compulsory licence (CL) in certain circumstances.

• At any time after the expiry of three years from the date of grant of the patent, any person interested makes an application to the Indian Patent Office (IPO) for a grant of a compulsory licence on any of the following grounds:
1. that the reasonable requirements of the public with respect to the patent invention had not been satisfied;
2. that the patented invention is not available to the public at a reasonably affordable price; or
3. that the patented invention is not used in the territory of India.
• The central government is satisfied, in a national emergency or in circumstances of extreme urgency, or in the case of public non-commercial use, that it is necessary that a CL should be granted, it may make a declaration to that effect, by notification.
• It is required to manufacture and export the patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector to address public health problems provided the CL has been granted by such country or such country has, by notification or otherwise, allowed the importation of the patented drug from India.

A proceeding for patent infringement can be brought by a patentee or a holder of an exclusive licence.

Further, the holder of a CL is entitled to call upon the patentee to bring such proceedings. If the patentee refuses or neglects to do so within two months after being called upon, they may institute proceedings in their own name, making the patentee a defendant.

The court may grant a relief that may include an injunction and, on the request of the plaintiff, either damages or an account of profits. The court may also order that the goods that are found to be infringing, and materials and implements used in the creation of the infringing goods, shall be seized, forfeited or destroyed, as the court deems fit under the circumstances of the case, without payment of any compensation.

The invalidity of the suit patent is an available defence in the proceeding of infringement and can be invoked by filing a counterclaim by the defendant in a suit for infringement.

The generic entrant may institute a suit for a declaration that their use of a product or process would not infringe a patent if it is shown that:

• the person applied in writing to the patentee or exclusive licensee for a written acknowledgment and furnished them with full particulars in writing of the process or article in question; and
• the patentee or licensee has refused or neglected to give such an acknowledgment.

The generic entrant may also initiate opposition or revocation proceedings challenging the validity of a patent. There is also an option of obtaining a compulsory licence under specific circumstances.

There is no patent linkage in India and clearing the way is not a requirement for generic market entry.

In recent patent infringement cases, the Indian courts have introduced the concept of "clearing the way". If a party intends to use a patented product or method, they must exercise due diligence. If they fail to "clear the way", then in a court proceeding the balance of convenience may shift in favour of the plaintiff and may enable the grant of an interim injunction against the said party.

India has no specific legislation and procedures for dealing with the counterfeiting of drug and medical devices; see 3.9 Border Measures to Tackle Counterfeit Pharmaceutical and Medical Devices.

The Trademarks Act, 1999 (the "TM Act") prohibits the registration of names of chemical elements or international non-proprietary names (INN) as trade marks in India. There are no restrictions under the TM Act to the importation and distribution of non-counterfeit, genuine pharmaceutical or medical device products from other markets, regions or countries.

Although trade dress is not specifically mentioned under the TM Act, the definition of a trade mark under the TM Act includes the "shape of goods, their packaging, and combination of colours". The aesthetics of any article or product of manufacture are protected and registered in India under the Designs Act, 2000 and the Designs Rules, 2001.

There are no provisions for data exclusivity in India. Under the DC Rules, a “new drug” continues to be considered as a new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. An applicant for a new drug is required to conduct extensive testing and clinical trials for obtaining market authorisation. Therefore, an application for manufacturing generic versions of a new drug during the four-year period is required to contain clinical trial data.

The central government, the CDSCO and other bodies issued various notices and guidelines to expedite the approval of COVID-19 drugs, diagnostic kits and vaccines. Some of them are listed below.

• A special notification regarding the conduct of clinical trials to make available suitable vaccines was issued by the central government.
• The CDSCO released an office memorandum dated 26 May 2020 providing for an expedited approval process for COVID-19 vaccines. As per the memorandum:
1. pre-clinical trial data generated abroad may be considered as part of an application to conduct clinical trials; and
2. clinical trial data generated outside India may be used to provide an abridged pathway for a COVID-19 vaccine.
• Provisions were made for high-priority processing of applications for R&D/repurposing/importation/manufacturing/marketing/evaluation of drugs or vaccines and diagnostic kits for COVID-19.
• “Draft Regulatory Guidelines for Development of Vaccines with Special Consideration for COVID-19 Vaccine” were issued by the CDSCO. The guidelines are in the nature of recommendations and do not replace any statutory requirements. The guidelines focus on safety, immunogenicity and efficacy parameters for developing COVID-19 vaccines. Some of the key points are:
1. the vaccine should be well characterised and manufactured consistently;
2. the vaccine candidate should have at least 50% efficacy in the Phase III clinical trial for it to be widely deployed;
3. adequate data providing information on the potential risk of vaccine-associated enhanced respiratory disease (ERD) needs to be generated;
4. the use of COVID-19 vaccines in pregnancy and in women of childbearing potential is an important consideration for vaccination programmes;
5. a vaccine should remain stable for the duration of the shelf life under recommended storage conditions;
6. adequate data should be generated in respect of the vaccine to establish safety and protective immunity; and
7. people previously infected should be included at the testing stage provided they do not have acute COVID-19 or another infection.
• Guidelines for validation and batch testing of diagnostic kits were issued by ICMR-DCGI.
• Provisions were made for relaxation of the data requirement and requirements for the importation licence.
• Emergency approvals for vaccines, Covidshield and Covaxin were granted subject to terms and conditions.
• Restricted emergency use and manufacture approvals were granted to Remdesivir and Favipiravir tablets.

The following special measures were issued in relation to ongoing clinical trials:

• a notice regarding the conduct of clinical trials during the COVID-19 outbreak was issued by the CDSCO in March 2020;
• the registrations of the BA/BE study centres were extended; and
• a clinical trial protocol for convalescent plasma was issued.

Please see 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices.

The DC Act contains provisions that allow the central government to regulate, restrict, manufacture, etc a drug in the public interest by way of notification in the Official Gazette.

Please refer to 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices, 11.2 Special Measures Relating to Clinical Trials, 11.4 Flexibility in Manufacturing Certification as a Result of COVID-19 and 11.5 Import/Export Restrictions or Flexibilities as a Result of COVID-19 for details.

The following simplifications and flexibility were introduced in relation to obtaining required certifications due to COVID-19:

• manufacturers of industrial oxygen were allowed to manufacture oxygen for medical use subject to conditions;
• the processing of applications to manufacture hand sanitisers was done in three working days;
• hand sanitisers were exempted from the requirement of a sale licence;
• the validity of WHO Good Manufacturing Practice and the Certificate of Pharmaceutical Products expiring from March to August 2020 was extended by six months; and
• prior permission from the CLA for manufacturing and stocking a vaccine for COVID-19 was deferred.

The following import/export restrictions or flexibilities were introduced in relation to medicines or medical devices due to COVID-19:

• export restrictions were imposed on 26 API and formulations made therefrom;
• Draft New Drugs and Clinical Trials (Amendment) Rules, 2020 were issued for compassionate use of any new unapproved drug;
• the exportation of items such as surgical or medical masks, medical coveralls, medical goggles, nitrile/nitrile butadiene rubber gloves, face shields and PPE coveralls was either completely restricted or limited to a certain quota;
• the validity of registration certificates or licences for the importation of drugs that were due to expire was extended subject to conditions;
• special conditions under which permission for the importation of drugs with a residual shelf life of less than 60% was to be allowed/extended were specified;
• a set of regulations were issued to allow for certain norms to be relaxed to facilitate ease in the importation and exportation of COVID-19 vaccines through a courier; and
• the submission of applications for import registration for drugs, cosmetics and medical devices with self-attested documents was allowed subject to conditions.

Please see 8.5 Online Sales of Medicines and Medical Devices and 8.6 Electronic Health Records.

No such announcement has been made so far. Regarding the rules, please refer to 9.5 Defences to Patent Infringement in Relation to Pharmaceuticals and Medical Devices.

The government has no proposal to indemnify or exempt vaccine manufacturers from any liability in the event of serious adverse reactions or side-effects due to vaccines.       

Please see 11.4 Flexibility in Manufacturing Certification as a Result of COVID-19.

In 2017, the central government issued Public Procurement (Preference to Make in India) [PPP-MII] Order 2017 (with subsequent revisions in 2018–20) to encourage "Make in India" and to promote the manufacturing and production of goods, services and works in India with a view to enhancing income and employment where there is sufficient local capacity and competition.

To implement the Order, the Department of Pharmaceuticals (DoP) issued Guidelines in relation to the procurement of medical devices in 2018. The Guidelines were further revised in 2021.

Similarly, in 2021, the DoP issued Guidelines (in supersession of the earlier Guidelines) for implementing the Order in relation to the procurement of pharmaceutical formulations.

There has been no change due to COVID-19.