The Drugs and Cosmetics Act, 1940 (DCA) regulates the import, manufacture and distribution of medical devices in India, and the sale of drugs and cosmetics, ensuring their safety, quality and efficacy. Pursuant to the DCA, various rules have been notified periodically to govern the manufacture, sale and regulation of pharmaceutical products and medical devices. The relevant rules are as follows.

• The Drugs and Cosmetics Rules, 1945 (DCR) give detailed procedures regarding implementing the DCA, including requirements for licensing, packaging and labelling, manufacturing conditions, and rules governing the import of both drugs and medical devices. Recent amendments to these Rules have introduced measures such as QR code‑based traceability and stricter controls on blood banks and contract manufacturing.
• The Medical Devices Rules, 2017 (MDR) provide a complete framework for regulating medical devices at every stage of their life cycle. They cover manufacturing, import, quality standards, labelling, sales and clinical investigations. The rules also promote transparency and efficiency by permitting electronic applications through the online SUGAM portal.
• The New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) were implemented to promote increased clinical trials by streamlining approvals, reducing timelines and creating a transparent regulatory framework. The rules broadened the definition of “new drug” to cover novel products like vaccines and stem cell therapies, and allowed for waivers of novel drugs that have been approved in certain countries (eg, the United States, the European Union, the United Kingdom). It also mandated registration and periodic training for ethics committees, and established mechanisms for compensation for trial-related injuries or death.

In addition to the above, there are multiple ancillary pieces of legislation and codes governing various aspects of pharmaceuticals and medical devices, including the following.

• The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) controls the cultivation, manufacture, possession, purchase, transport, storage, sale and use of “narcotic drugs” (including coca leaf, cannabis, opium, poppy straw and other manufactured drugs) and narcotic substances for medical, scientific and industrial purposes. The framework imposes strict controls and severe penalties for non‑compliance or misuse.
• The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA) controls and regulates drug advertising, banning ads for remedies claiming magical cures, and making such promotions a cognisable offence in order to prevent the exploitation of superstition, covering magic, human sacrifice and false cures for ailments. It bans the advertising of certain drugs and prohibits magic remedies or rituals claimed to cure diseases.
• The Uniform Code for Pharmaceutical Marketing Practices and the Uniform Code for Marketing Practices of Medical Devices are self-regulatory guidelines from India’s Department of Pharmaceuticals (DoP) in order to curb unethical promotion, ensuring transparency and accountability by banning gifts, excessive hospitality and financial incentives to healthcare professionals, while mandating declarations, compliance training and robust complaint/appeal mechanisms for both pharma and device companies.
• The Drugs (Prices Control) Order 2013 (DPCO) is issued under the Essential Commodities Act, 1955 (ECA) to regulate the prices of prescribed essential medicines, in order to ensure their affordability and availability. The National Pharmaceutical Pricing Authority (NPPA) enforces these prices.

Regulatory Bodies

Under the Ministry of Health and Family Welfare

• The Central Drugs Standard Control Organisation (CDSCO) functions as India’s National Regulatory Authority under the Directorate General of Health Services within the Ministry of Health and Family Welfare (MoHFW). It is led by the Drugs Controller General of India (DCGI), which oversees drug approvals and clinical trial regulation, and serves as the Central Licensing Authority (CLA). CDSCO establishes drug standards, monitors the quality of imported medicines, and works with State Drug Control Organisations (SDCOs/SLAs) to ensure uniform enforcement of the DCA. In addition, the CLA, together with the SLA, issues licences for certain critical and specialised drug categories, including blood and blood products, intravenous fluids, vaccines and sera.
• SDCOs/SLAs are the primary regulators for the manufacture, sale and distribution of drugs and cosmetics within their respective states, functioning under the DCA. They are responsible for licensing, inspections and ensuring compliance with quality and safety standards at the state level. While SLAs operate independently under state governments, they co-ordinate with CDSCO/CLA, which provide national standards, expert guidance and oversight to promote uniform enforcement of drug regulations. Advisory bodies such as the Drugs Technical Advisory Board and the Drugs Consultative Committee under CDSCO support this harmonisation by offering recommendations to both central and state governments.
• The Drugs Technical Advisory Board (DTAB) serves as the apex statutory body for making technical decisions on drug-related matters in India. As part of the CDSCO framework, it provides expert guidance to both central and state governments on issues concerning the DCA, and performs the responsibilities assigned under the Act.
• The Drugs Consultative Committee (DCC) is another statutory body established under the DCA, designed to ensure uniform implementation of drug regulations nationwide by advising central and state governments along with the DTAB on all matters related to drug administration, quality and safety. It bridges the gap between central and state drug control authorities for consistent law enforcement. Primarily, it works on regulatory harmonisation, including licensing, labelling, standards and related technical matters.
• The Indian Pharmacopoeia Commission (IPC) is an independent body responsible for establishing standards for all drugs manufactured, marketed and used within India. IPC became fully operational in 2009 and is financed by the central government, with budgetary allocations under the administrative control of the MoHFW. It is considered to be India’s official body of standards for drugs, providing authoritative procedures, specifications for identity, purity and strength, and legally enforceable quality benchmarks for medicines manufactured, sold or distributed in the country.

Under other ministries

• The NPPA is an independent body, established in 1997 to regulate the prices of essential medicines, ensuring they are affordable and accessible to the public. The NPPA is a part of the DoP, which comes under the Ministry of Chemicals & Fertilisers. It fixes and revises drug prices under the DPCO and monitors drug availability, prevents overcharging by manufacturers, and advises the government on pharmaceutical policies.
• The Central Bureau of Narcotics (CBN) is a central law enforcement and regulatory agency under the Department of Revenue, which is a part of the Ministry of Finance. It oversees illicit opium cultivation, controls narcotic and psychotropic substances, regulates their import/export, and enforces laws through licensing and investigations.

CDSCO and SDCOs

If any person/organisation wishes to appeal against the order of a CLA or SLA, this may be done before the central government or the state government, respectively. Upon filing an appeal, the appellant may then be given an opportunity to present their case, and an order to that effect may be issued.

The timelines for filing an appeal are defined under the DCR and the NDCT Rules with respect to pharmaceuticals, and under the MDR with respect to medical devices, and vary depending on the type of appeal (rejection of application to conduct clinical trial, suspension of registration/licence by an authority, etc).

Aggrieved parties may also approach the appropriate High Court under writ jurisdiction under apposite facts and circumstances.

NPPA

Aggrieved parties may file for a review of an NPPA notification/order directly with the DoP within 30 days of the publication thereof (Rule 31 of the DPCO). Alternatively, the party may also approach the appropriate High Court under writ jurisdiction under apposite facts and circumstances.

DTAB, DCC and IPC

Both the DTBA and the DCC have an advisory role only; recommendations passed by them do not have any binding effect, so no appeals are provided for under the statutes. Similarly, since the IPC is an autonomous body with no regulatory, approval or enforcement role, no appeals are provided specifically.

CBN

Grievances are generally considered by the Narcotics Commissioner or Additional/Joint Secretary (Narcotics), at first instance. Appeals beyond this lie before the respective High Courts.

Application to Other Regulated Products

Please note that the above challenge procedure is only applicable for products falling within the purview of “drug” under Section 3(b) of the DCA and “medical device” defined under Rule 3(zb) of the MDR (as the case may be). Therefore, if a regulated product (such as a food item) would fall within the above-provided definitions, the challenge procedures mentioned above would apply accordingly.

Pharmaceuticals

Under the DCR framework, pharmaceuticals are regulated as:

• prescription drugs, which require a doctor’s prescription; or
• non‑prescription or over‑the‑counter (OTC) drugs.

These are further classified in the following sub-groups.

Prescription-only medicines

• Schedule H covers those medicines that can be sold only on the prescription of a registered medical practitioner and must not be advertised to the public (eg, amoxicillin, used to treat bacterial infections such as respiratory tract infections).
• Schedule H1 includes certain critical antibiotics and habit‑forming drugs that require a prescription, mandatory record‑keeping by pharmacists, and stricter monitoring to prevent misuse and antimicrobial resistance (eg, cefixime, used for typhoid fever and other serious bacterial infections).
• Schedule X contains narcotic and psychotropic medicines with high abuse potential, which require a special prescription, duplicate record maintenance, and tighter controls on storage and sale (eg, morphine, used for severe pain management, such as in cancer patients).

Additionally, Schedule G drugs are those which are not technically strictly prescription-only medicines like Schedule H, but they must be used only under medical supervision. Their labels must display the caution: “It is dangerous to take this preparation except under medical supervision.” Such drugs are supervised-use drugs, not general OTC, and carry a high risk if taken without a doctor’s advice. Examples include aminopterin, used to treat paediatric leukaemia and psoriasis.

OTC medicines

These are drugs that can be sold by a pharmacist without a doctor’s prescription.

Currently, OTC medicines are not formally defined in any legislation. In practice, they include non‑prescription drugs outside Schedules H/H1/X, such as fever remedies, antifungals, antiseptics, vitamins and wellness products. Regulators are moving toward a formal OTC framework with a separate schedule and clear labelling and licensing norms, as recommended by the DTAB, to streamline regulation and approvals.

Apart from OTCs, India also has Schedule K drugs listed under the DCR, and specifies classes of drugs that are exempt from certain licensing requirements, subject to stated conditions.

In May 2022, the government of India issued a draft notification proposing to add a starter list of 16 OTC medicines (eg, paracetamol 500mg, clotrimazole cream, povidone‑iodine solution) with safeguards like a five‑day maximum use, limited pack sizes, a mandatory Patient Information Leaflet, and a direction to consult a doctor if symptoms persist.

Medical Devices

Based on invasiveness, contact with the body, duration and intended use, under Schedule I of the MDR, medical devices are regulated under a risk-based classification in the following manner:

• Class A – devices with minimal potential harm and simple design, such as thermometers or tongue depressors;
• Class B – devices with limited risk requiring regulatory control, such as hypodermic needles or suction catheters;
• Class C – devices that sustain life or have long‑term body contact, such as infusion pumps or orthopaedic implants; and
• Class D – devices that are life‑supporting or life‑sustaining and pose the highest risk, such as heart valves or coronary stents.

Clinical trials in India are regulated by the DCA, the DCR and the NDCT Rules for pharmaceuticals, and under the MDR for medical devices using a risk‑based approach. In both cases, CDSCO and the DCGI are the central authorities responsible for granting approvals, and prior approval from a DCGI‑registered Ethics Committee is mandatory before trial initiation. The NDCT Rules and MDR prescribe the procedures for application, review timelines, and the conduct of trials and clinical investigations.

Both pharmaceuticals and medical devices have separate procedures to secure an authorisation to undertake a clinical trial.

Pharmaceuticals

The procedures are as follows.

• Ethics Committee registration: clinical trials for pharmaceuticals in India are regulated under the DCA and the NDCT Rules. The procedure is overseen by CDSCO. Under the NDCT Rules, an Ethics Committee must have at least seven members and obtain registration from the CLA by applying with required documents; if the CLA is satisfied, it grants approval that is valid for five years.
• Site‑specific Ethics Committee approval: anyone planning to conduct a clinical trial must first obtain approval of the study protocol from a registered Ethics Committee, which is responsible for reviewing and monitoring the trial before it begins and throughout its duration. Any serious adverse events must be reported to the Ethics Committee, the CLA and the host institution within the mandated timeframes. In addition, trial sites must remain accessible for inspections by CLA or SLA officials, or other authorised experts, to ensure compliance with regulatory requirements.
• Application to the CLA (DCGI) for clinical trial permission (Form CT-04 using the SUGAM portal): following the Ethics Committee’s approval, the applicant submits the protocol and required documents to the CLA. For new drugs or investigational new drugs discovered or developed in India, the CLA is required to either approve or reject the application within the specified timeline. If no response is issued within that period, the authorisation is considered to have been granted by default. Trials can start only after site‑specific Ethics Committee approval is received, and the study must be registered on the Clinical Trials Registry of India (CTRI) before enrolling participants.
• Regulatory review and query responses: CDSCO conducts its regulatory review of the submitted dossier, during which the sponsor must address any regulatory queries raised. Upon satisfaction, the DCGI issues written approval in Form CT‑06.
• Ongoing reporting and trial conclusion: sponsors are responsible for ensuring medical treatment and compensation in the event of trial‑related injuries, deaths or permanent disabilities. They must also provide periodic updates, such as quarterly enrolment figures and biannual progress reports. If the study is discontinued, they must submit a detailed explanation to the CLA. Throughout the duration of the trial, sponsors must keep all sites accessible for regulatory inspections.

Medical Devices

The procedures are as follows.

• Determine device risk class: clinical investigations of medical devices in India are regulated under the MDR and are based on a risk‑based classification system (Class A to Class D). Sponsors must first determine the device risk class and prepare a Clinical Investigation Plan, along with technical, pre‑clinical and safety data.
• Ethics Committee registration and approval: prior approval from a CDSCO‑registered Ethics Committee is mandatory, with a focus on participant safety, informed consent and risk management. The Ethics Committee reviewing an investigational medical device study must be duly registered with the CLA under the MDR. The sponsor proceeds to the regulatory application phase with the CLA only after receiving Ethics Committee approval.
• Application to the CLA (CDSCO) for clinical investigation permission (Form MD-22): the sponsor submits an application to the CLA seeking permission to conduct the pivotal clinical investigation. The CLA reviews the application to assess the device’s safety, performance and intended use before granting authorisation.
• CTRI registration before first enrolment: once approved, the clinical investigation may commence subject to the approved plan and Good Clinical Practice. It must be registered with the CTRI before enrolment, with annual status reports to the CLA, and notification (with reasons) must be provided if the investigation is terminated.
• Conduct and Good Clinical Practice: suspected serious adverse events must be reported to the CLA, and sponsors must provide medical management and compensation for injury or death. It is important to note that sites and sponsor premises are subject to CLA inspections. The first participant must be enrolled within one year of permission (else prior CLA approval is required), and non‑compliance may lead to the suspension or cancellation of permission.

The public availability of details regarding the conduct of a clinical trial for medical devices or medicines is a necessity, but the public availability of the results is not mandatory as per the registry.

Under the Indian regulatory requirements, trial registration is compulsory before the first participant is enrolled. This is enforced by the DCGI through the CTRI, a publicly accessible registry under the Indian Council of Medical Research). The CTRI is recognised as a primary registry in the World Health Organization (WHO), and all clinical trials must be registered there in context of India, including trials of drugs and vaccines.

Registered trials are searchable and include the trial title. Designs, interventions, sponsors and outcomes are freely accessible on the CTRI website via the WHO portal. However, public reporting of detailed trial results is not yet a stringent statutory requirement on the CTRI website. Although the CTRI and regulators strongly encourage transparency in reporting results and India is a signatory of the WHO joint statement advocating for transparency in the disclosure of results, there is no specific mandate with timelines for submitting such structured result summaries on the CTRI.

In India, the use of online and digital tools in clinical trials is subject to a defined regulatory framework. The study design – including elements such as digital participant recruitment, electronic informed consent (e‑consent) and remote monitoring – must first be reviewed and approved by the Ethics Committee and CDSCO, in accordance with the NDCT Rules for drugs and the MDR for medical devices. Once regulatory approval is granted, any digital collection, use or processing of participant data must comply with the Digital Personal Data Protection Act, 2023 (DPDP Act) and the rules thereunder (DPDP Rules).

Accordingly, data fiduciaries must comply with core requirements, including:

• providing clear notice and obtaining free, informed and express consent;
• processing data only for approved and specified purposes;
• implementing appropriate technical and organisational security measures;
• ensuring contractual safeguards with third‑party processors;
• implementing adequate breach reporting mechanisms;
• erasing personal data once the purpose of processing is fulfilled; and
• enabling data principal rights, such as access, correction, erasure, grievance redressal, nomination and withdrawal of consent.

The information generated in a clinical trial qualifies as personal data when it can reveal an individual’s identity and indicate the health condition they are experiencing. Sharing such data with third parties may trigger legal obligations. This assessment is context‑specific and depends on the type of data produced during the trial. For instance, raw datasets often contain personally identifiable details, which would be considered personal data under the DPDP Act and the DPDP Rules.

In light of the provisions of the DPDP ACT and the DPDP Rules, all or any instances of cross-border data transfer of personal data shall be restricted to regions and/or nations restricted by the central government by means of a special or general order. In addition, it is mandatory to inform the individual about all or any forms of cross-border data disclosure prior to seeking informed consent.

In addition to the obligations of a data fiduciary under the DPDP ACT, it is mandatory for the data fiduciary to deploy adequate technical measures, including but not limited to encryption, masking, access restriction, etc, to ensure the security, confidentiality and integrity of the personal data at rest as well as in transit.

If such cross-border data transfer is undertaken to a data processor based outside India, the data fiduciary shall be responsible for ensuring compliance on behalf of the contractually appointed data processors.

The IDPDP ACT and the DPDP Rules do not establish any forms of segregation between personal data and sensitive personal data, so the obligations of a data fiduciary under the DPDP ACT shall be applicable irrespective of the type of personal data collected and processed. Therefore, no forms of additional or further requirements shall be triggered under the DPDP ACT. However, it may be noted that the provisions of the DPDP ACT are not yet in effect; until they come into effect, the provisions of the Information Technology Act, 2000 (including the SPDI Rules, 2011) would be in effect. The SPDI Rules do, however, segregate personal data into normal and sensitive personal data.

The assessment process for determining whether a product is a pharmaceutical or a medical device is as follows.

Pharmaceuticals

If a product is intended for the diagnosis, treatment, mitigation or prevention of disease by pharmacological, immunological or metabolic action, it is determined as a “drug” under Section 3(b) of the DCA. The determination is made based on the primary intended use and dominant mode of action, as evidenced by the product’s composition, labelling, claims and mechanism of action.

Upon classification as a drug, the product is required to comply with Chapter IV of the DCA, including obligations relating to manufacturing licence, regulatory approvals by CDSCO or the SLA, clinical data where applicable, and prescription controls.

Medical Devices

On the other hand, if a product is intended for the diagnosis, prevention, monitoring or treatment of disease primarily by physical, mechanical or structural means, it is determined as a “medical device”, as statutorily defined under Section 3(b) of the DCA and Rule 2(zb) of the MDR.

The classification of a product as a medical device is determined with reference to its intended purpose, principal mode of action and risk profile, and such devices are categorised into Class A to Class D in accordance with Schedule I of the MDR (see 1.3 Categories of Pharmaceuticals and Medical Devices). Upon classification as a medical device, the product is required to comply with the risk‑based regulatory framework, including applicable conformity assessment procedures, quality management system requirements, registration or licensing, and post‑market surveillance obligations, in lieu of the drug approval pathway.

Notably, a draft bill titled New Drugs, Medical Devices and Cosmetics Bill, 2022 is underway, which seeks to replace the DCA. The Bill proposes a separate and modern regulatory framework for medical devices, distinct from drugs, with device‑specific definitions, approvals and oversight. It introduces a dedicated advisory board, strengthens powers for recalls and emergency approvals, and promotes digital, risk‑based regulation with improved Centre–State co-ordination.

In India, biological medicinal products are not subject to a separate approval pathway under the NDCT Rules and are regulated in the same manner as other new drugs. As a rule, local clinical trials are required to establish safety and efficacy, unless a waiver is granted by the CLA. Where a biological product involves hazardous micro-organisms or genetically engineered organisms, an additional biosafety approval from the Review Committee on Genetic Manipulation is required. Biological products – including vaccines, recombinant DNA-based products, monoclonal antibodies, and cell or gene therapies – are treated as new drugs indefinitely under the NDCT Rules, unlike small molecule drugs, which lose this status after four years.

Consequently, significant modifications or new versions of a biological product may trigger fresh clinical trial requirements. For instance, under the Guidelines on Similar Biologics, 2016, biosimilar (generic versions of biologics) marketing authorisation is subject to a step‑wise comparability exercise demonstrating similarity to a licensed reference biologic in terms of quality, safety and efficacy, based on extensive analytical characterisation, manufacturing consistency and quality data. This must mandatorily be supported, as required, by non‑clinical and clinical studies (including pharmacokinetic and pharmacodynamic immunogenicity, and confirmatory safety/efficacy where necessary), along with a post‑marketing pharmacovigilance plan, before approval is granted by CDSCO.

Period of Validity and Renewal of Marketing Authorisation

Under the NDCT Rules, the DCR, the DCA or the MDR, pharmaceutical marketing authorisations in India are currently valid indefinitely, provided a specified retention fee is paid every five years. Medical device licences are also perpetual, subject to the payment of a five-yearly retention fee under the MDR.

Cancellation and Suspension of Licences

Pharmaceuticals

Under the DCR, the CLA has the power to suspend or cancel a pharmaceutical licence if the licensee fails to comply with any condition of the licence or violates any provision of the DCA or the DCR. This may include, among other grounds:

• failure to place the authorised drug on the market or to maintain its supply;
• non‑compliance with approved quality, safety or efficacy specifications;
• breach of labelling or packaging requirements;
• failure to submit Periodic Safety Update Reports (PSURs) or adverse event reports; or
• any situation where continued marketing may pose a risk to public health.

Such action can only be taken after giving the licensee an opportunity to show cause, and the authority must issue a reasoned written order. Where the non‑compliance arises due to the act or omission of an agent or employee, the licence will not be cancelled or suspended if the licensee can demonstrate that:

• the contravention was not instigated or connived;
• due diligence was exercised; and
• there was no prior similar misconduct within the preceding 12 months, or that the licensee could not reasonably have had knowledge of such misconduct.

Medical devices

Under the MDR, the competent authority (CLA or SLA as the case may be) may suspend or cancel a marketing authorisation, wholly or in part, where the licensee contravenes any provision of the DCA or the DCR. Such action must follow due process, including giving the licensee an opportunity to show cause, and must be supported by a reasoned written order specifying the grounds for suspension or cancellation.

Obtaining Marketing Authorisation

Pharmaceuticals

The manufacturer or importer must submit a marketing authorisation application under the NDCT Rules, with clinical, preclinical and formulation data. The CLA then reviews the application and may request additional information to ensure safety, efficacy and quality. If satisfied, the CLA grants marketing permission, after which the manufacturer must obtain a manufacturing or import licence under the DCA and the DCR.

Medical devices

The manufacturer must submit a marketing authorisation application for medical devices to the relevant authority (SLA or the CLA, as the case may be) under the MDR, including details on intended use, safety and performance. The applying pathway depends on device class (A–D):

• for Class A/B products, applications are submitted via Form MD-3 to the SLA; and
• for Class C/D and IVDs, submission is via Form MD-7 to the CLA, accompanied by the relevant documents.

The relevant authority then reviews the application and, if satisfied, grants marketing permission, after which the applicant can obtain a manufacturing or import licence. Any major changes affecting quality, safety, performance or intended use require prior CLA approval before implementation.

Changes in Approved Drugs/Medical Devices

Pharmaceuticals

Any post‑approval change is first assessed against Rule 2(w) of the NDCT Rules, which treats certain changes as a “new drug”. Changes such as therapeutic indication, posology, patient population, route of administration, or formulation are treated as a subsequent new drug. For such changes, the marketing authorisation holder must apply to CDSCO (CLA) through the SUGAM portal. The application must include supporting CMC, non‑clinical and/or clinical data, depending on the nature of the change. The CLA reviews the application (it may seek an expert opinion) and issues prior approval before the change can be implemented.

Labelling or packaging changes that affect approved indications, dosage, warnings or directions for use also require prior CDSCO approval; purely cosmetic changes are generally handled by notification.

Medical devices

Post‑approval changes are classified under the MDR (Sixth Schedule) as major (requires prior approval) or minor (notify within 30 days).

• “Major changes” include updates to intended use/indications, design affecting performance/specifications, material of construction, method of sterilisation, shelf life, primary packaging, and changes to the name/address of the manufacturer/overseas site/authorised agent (imports).
• IVD/device guidance: CDSCO has issued post‑approval guidance (eg, stability packages to support IVD changes such as shelf life or packaging updates). Under this framework, when a post‑approval change may affect the performance or claimed shelf life of an IVD, the applicant is expected to submit appropriate stability data (eg, real‑time or accelerated studies, in‑use stability or transport stability, as relevant).

Third-party transfers

The marketing permission is issued specifically in the name of the applicant and its organisation, and cannot be transferred to another person or entity. Any person seeking to market the same medical device must submit a fresh application to the CLA and obtain a separate marketing permission.

The NDCT Rules provide for specific exceptions to assist individuals in need of life-saving drugs that may not otherwise be authorised for use/supply in India. This mechanism applies where the patient suffers from a life‑threatening disease, a disease causing serious permanent disability, or a condition with unmet medical needs, and where the drug is approved in the country of origin or is under clinical trial in India.

Supply is permitted either through import or limited manufacture, solely for patient‑specific treatment, and commercial sale is expressly prohibited. It requires prior permission from the CLA, is time‑limited, quantity‑restricted, subject to strict record‑keeping, reporting, inspection and adverse event reporting obligations, and may be suspended or cancelled for non‑compliance. Individuals may also import small quantities of such drugs for personal use with CLA approval and a valid prescription.

In India, the holder of a medical device/pharmaceutical marketing authorisation is mandatorily required to conduct technovigilance and pharmacovigilance.

For pharmaceutical drugs, mandatory pharmacovigilance includes the detection, assessment and prevention of adverse drug reactions, along with the preparation and submission of PSURs to the CLA. The CLA may impose post‑marketing commitments, including Phase IV clinical trials, particularly when approvals are granted on limited clinical data or accelerated pathways, or for products addressing unmet medical needs. Pursuant to the Fifth Schedule (read with Rules 77 and 82) of the NDCT Rules, such obligations are typically applied to new drugs, biologics, vaccines and products requiring long‑term safety evaluation. The purpose is to ensure the monitoring of rare adverse events, real‑world effectiveness and long‑term risk–benefit assessment after the product enters the market.

For medical devices, once a company obtains a licence, it must continue to monitor the safety and performance of the device after it is sold. This means the company must collect and report any adverse incidents, device problems or failures and take corrective actions if needed (such as repairs, warnings or recalls). Schedule VII Rule 3 of the MDR essentially outlines the framework for post‑approval changes, recalls and vigilance obligations, making it clear that manufacturers/importers must act immediately when a device poses a safety risk.

Third parties can view general status information on pending drug and medical device applications on the CDSCO website, but product-specific details remain accessible only to the applicant. Once approved, the basic details of drugs and medical devices (such as name and indication) are published by CDSCO and are publicly available, while application data is kept confidential until approval.

India does not have a dedicated statutory regime for protecting regulatory or commercially confidential information beyond this practice, but the protection of commercially confidential information related to individuals, to the extent it can be used to identify an individual, shall be regulated under the scope of the DPDP ACT, and hence a data fiduciary shall be liable to undertake the obligations specified under the DPDP ACT and DPDP Rules.

India’s regulatory framework provides accelerated or relaxed approval pathways for both medicines and medical devices in defined public interest circumstances.

Pharmaceuticals

The NDCT Rules empower the CLA to waive local clinical trials for certain new drugs on a case‑by‑case basis. This may occur where the drug is already approved and marketed in specified reference jurisdictions without major unexpected safety concerns, or where scientific evidence indicates that the drug is unlikely to behave differently in the Indian population.

In addition, the New Drugs and Clinical Trials (Amendment) Rules, 2026 introduce a “prior intimation” regime for the manufacture of certain drugs, enabling activities to commence upon regulator acknowledgement instead of waiting for formal approval. Permit timelines have also been reduced from 90 to 45 working days, effectively accelerating regulatory reviews.

Medical Devices

Under the MDR, the CLA may defer, abbreviate or waive clinical investigation/clinical performance evaluation requirements, on a case-by-case basis.

Pharmaceuticals

By a notification dated 7 August 2024, CDSCO exercised its powers to waive clinical trial requirements for the USA, the UK, Japan, Australia, Canada and the EU with respect to the following drugs:

• orphan drugs for rare diseases;
• gene and cellular therapy products;
• new drugs used in pandemic situations;
• new drugs used for special defence purposes; and
• new drugs having significant therapeutic advances over the current standard of care.

Medical Devices

The results of a clinical investigation may not be submitted if the investigational medical device has already received approval from the regulatory authorities of the UK, the USA, Australia, Canada or Japan and has been commercially available in that country for at least two years, and the CLA is satisfied with the existing evidence regarding its safety, performance and post‑market surveillance.

Pharmaceuticals

In India, there is no separate manufacturing plant authorisation requirement. Instead, the manufacturing or import licence application must include evidence that the manufacturing site (India or overseas) complies with Good Manufacturing Practices (GMP) enshrined under Schedule M of the DCR. Here, the manufacturing licence itself acts as the authorisation, subject to fulfilment of GMP obligations under Schedule M. Please see 3.3 Period of Validity of Marketing Authorisations and 3.4 Procedure for Obtaining a Marketing Authorisation regarding the detailed procedure with respect to said licences.

The 2023 revised version of Schedule M introduced a comprehensive Pharmaceutical Quality System, Quality Risk Management and Product Quality Review for inspectors to assess enhanced GMP elements and align them with the International Council for Harmonisation Q10 and WHO-GMP standards.

In practice, the relevant SLA, after considering evidence of Schedule M compliance, issues a Schedule M/GMP compliance certificate as a pre‑condition. Pre‑licensing GMP inspections are mandatory and are conducted by the relevant drug inspectors.

Medical Devices

For medical devices, just like pharmaceuticals, no separate, standalone plant authorisation is required. However, for a manufacturing or import licence, applicants must show that the site operates an acceptable Quality Management System (eg, ISO 13485) and must comply with the MDR.

Wholesale sales, stocking or distribution of pharmaceuticals and medical devices require a wholesale licence granted by the respective SLA. The licence is issued on application in the prescribed form after the SLA verifies that there are adequate premises, storage conditions and competent staff, and it authorises the wholesale stocking and sale of drugs, including medical devices.

A wholesale licence under the DCR also permits the stocking and sale of medical devices, while entities dealing only in medical devices may instead obtain a registration certificate under the MDR, with fewer premises requirements. The wholesale licence is valid in perpetuity, subject to the payment of a retention fee every five years, failing which the licence is deemed cancelled.

As detailed in 1.3 Categories of Pharmaceuticals and Medical Devices, the DCR sets the following classifications:

• Schedule H are prescription‑only medicines;
• Schedule H1 consists of drugs that have a high risk of misuse, but does not include narcotic or psychotropic drugs;
• Schedule X consists of narcotic or psychotropic drugs that have a very high potential for misuse;
• Schedule G drugs are usually taken under medical supervision only; and
• OTC drugs are non-scheduled or non-prescribed drugs that are not covered under Schedule H, H1 or X.

Certain products exempted under Schedule K may also be sold without a prescription, subject to the specific conditions laid down therein.

DCA and DCR

The DCA and DCR regulate the import of drugs into India and require importers to obtain a registration certificate and an import licence. The import of medical devices is regulated under the DCA read with the MDR, and requires an import licence, while exports of drugs and devices do not require licences under this framework. Furthermore, the CLA grants import licences for drugs and medical devices. It reviews applications to ensure compliance with statutory, safety and quality requirements before permitting import.

Foreign Trade (Development and Regulation) Act, 1992 (FDTR Act)

The FTDR Act governs the trade control aspects of importing and exporting pharmaceuticals and medical devices in India. Under this Act, the Director General of Foreign Trade (DGFT) regulates such products through the Foreign Trade Policy and ITC (HS) classification, requiring licences or authorisations where drugs or devices are restricted or prohibited. Customs authorities enforce these controls at ports of entry and exit, while the DGFT oversees post‑trade compliance and penalties.

Customs Act, 1962

The Customs Act regulates customs clearance procedures at ports of import and export. Importers and exporters must accurately declare goods, ensure correct classification and valuation, pay applicable duties, and submit prescribed documents such as Bills of Entry and Shipping Bills. The Central Board of Indirect Taxes and Customs administers customs laws and enforces import and export controls at ports, to facilitate trade and prevent smuggling and duty evasion.

NDPS Act

This Act applies where the imported or exported product contains narcotic drugs, psychotropic substances or controlled precursors. It mandates additional licences and authorisations to prevent misuse, diversion and illegal trafficking. Under this Act, the CBN regulates the import and export of narcotic drugs, psychotropic substances and controlled precursors. It issues specific authorisations and monitors compliance under the NDPS Act framework.

The MDR and CDSCO Guidelines

India regulates imported medical devices under the MDR and CDSCO guidelines. Foreign manufacturers cannot apply directly; they must appoint an Authorised Indian Agent who meets MDR eligibility (including appropriate wholesale licensing) and shares responsibility for compliance, vigilance/recall and correspondence with CDSCO. The MDR uses a risk‑based classification and ensures device quality, safety and effectiveness before market entry, to avoid customs delays and enforcement actions. A CDSCO import licence is required to legally introduce medical devices into India.

A foreign manufacturer must obtain an import licence through an agent authorised in India, who acts as the importer of record for drugs or medical devices in India and would be responsible for regulatory compliance and the liabilities of the foreign manufacturer in India.

For pharmaceuticals and medical devices, the Importer of Record (Agent in India) must be an entity that:

• holds a valid licence to either manufacture or sell wholesale drugs under the DCA and the DCR;
• is authorised to import drugs into India; and
• holds a valid Power of Attorney, which must be duly executed and authenticated either in India before a First-Class Magistrate or before any other equivalent authority in the country of origin.

Pharmaceuticals

Anyone importing drugs (finished formulations or active pharmaceutical ingredients) must hold a valid CDSCO import licence (Form 10 and Form 10A, issued after Registration under Form 41 under the DCR) issued via the SUGAM portal. Without it, shipments will be detained at customs.

Exemptions

Personal use exemption (small quantities) (applied under Form 12A)

India allows individuals to import smaller quantities of drugs for one’s own individual use under certain conditions. This is typically meant for patients importing medicines that are not available in India and is an exemption for drugs, not for higher risk medical devices. Some low‑risk devices may still be brought in personal baggage when not intended for commercial use, but this is examined on a case‑specific basis by customs and CDSCO.

Emergency or compassionate use (including COVID‑19 situations)

India temporarily issued guidelines permitting the emergency importation of certain products without the usual full registration process – eg, COVID‑19 vaccines approved by major regulators.

Medical Devices

All medical devices require a CDSCO import licence under the MDR (Forms MD-14 and MD-15 of the MDR). The approval is based on risk classification (Class A–D), device master file, conformity with GCP/GMP, and the appointment of an Indian Authorised Agent.

There is no formal exemption, except discretionary leniency for low‑risk non‑commercial items.

The import of drugs and medical devices into India is controlled by strict regulatory rules. Every product is classified using an Indian Trade Classification (Harmonised System) Code, issued by the DGFT, under the FTDR Act. Anyone importing these products must have an Importer-Exporter Code for customs clearance.

Non-tariff regulations on drugs and medical devices in India are imposed as follows (see 7.1 Governing Law and Relevant Enforcement Bodies and 7.2 Importer of Record of Pharmaceuticals and Medical Devices):

• to import drugs, companies must obtain a Registration Certificate and an import licence under the DCA and the DCR; and
• to import medical devices, the foreign manufacturer’s Authorised Indian Agent (or Indian subsidiary) must obtain an import licence under the MDR issued only by the CLA/SLA as the case may be.

As a member of the WTO, India participates in several regional and bilateral trade arrangements, such as SAARC, ASEAN-India FTA, APTA and the India MERCOSUR PTA. Notably, the India–UAE CEPA includes a dedicated pharmaceutical annex providing for regulatory co-operation and fast-track approvals for certain approved pharmaceutical and biologic products, to ease market access.

Recent Free Trade Agreements

India’s new free trade agreements (India–EU and India–US) could have improved market access for pharmaceuticals and medical devices.

India exercises significant statutory control over the pricing of pharmaceuticals and, to a more limited and product‑specific extent, medical devices. The principal legislation governing price regulation is the DPCO, issued under the ECA. The DPCO is administered and enforced by the NPPA.

While the DPCO was originally intended for pharmaceuticals, its scope has been extended to certain notified medical devices, particularly those included in the National List of Essential Medicines (NLEM) or separately notified by the government for price regulation.

Products Included in the NLEM

Pharmaceutical formulations and notified medical devices included in the NLEM are subject to government‑fixed ceiling prices determined by the NPPA. The ceiling price represents the maximum retail price (MRP) at which the product may legally be sold to distributors and retailers. The MRP is calculated as the ceiling price plus applicable local taxes, and no manufacturer, importer, wholesaler, distributor or pharmacy may charge above the MRP. This mechanism effectively controls:

• the manufacturer’s ex‑factory price; and
• the final selling price to the consumer, thereby indirectly regulating the margins available to wholesalers and retailers.

Products Outside the NLEM

For drugs and medical devices not included in the NLEM, the NPPA does not ordinarily fix ceiling prices. However, manufacturers and importers are subject to price‑increase restrictions and may not increase the MRP beyond 10% in any rolling 12‑month period. Where the increase is beyond 10% of the MRP, it shall reduce the same to the level of 10% of the MRP for next 12 months.

Trade Margins

The NPPA factors a defined retailer margin, typically around 16%, into the calculation of ceiling prices for price‑controlled products. In addition, it increasingly applies Trade Margin Rationalisation, which caps the total margin between the manufacturer’s price and the MRP.

Under India’s regulatory framework, international prices are not an official determinant for price fixation, and India does not follow an external reference pricing mechanism, unlike certain other jurisdictions that benchmark domestic prices to foreign markets. Pricing rules for medicines and medical devices in India fall under the DPCO, with the NPPA being responsible for implementing and overseeing those controls.

India does not operate a universal reimbursement system for pharmaceuticals or medical devices. Reimbursement from public funds is scheme‑based, eligibility‑driven and primarily linked to public health insurance and welfare programmes, rather than individual product reimbursement, as seen in some OECD countries. As a result, reimbursement occurs only in specific circumstances and for defined beneficiary populations. Examples of such government schemes include the following.

• The Ayushman Bharath Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) provides INR500,000 (approximately EUR 5,000) per year of a cashless coverage to each family, which includes secondary and tertiary medication like drugs, diagnostic services, devices used in various treatments, etc, when received at empanelled providers.
• The Central Government Health Scheme (CGHS) reimburses or provides free or subsidised medicines and select medical devices to eligible government employees, pensioners and dependents through dispensaries of the CGHS or approved providers.
• State insurance schemes, such as Medical Insurance Scheme for State Employees and Pensioners (MEDISEP) or Karunya Healthcare Scheme (KHS), provide reimbursement or cashless benefits for expensive treatments, including devices used in hospital care for targeted population or state government employees.
• The Employees’ State Insurance Scheme covers insured workers in the organised sector earning below the statutory wage threshold and their families.

To qualify for a reimbursement, beneficiaries must be eligible under the relevant scheme, and treatment must be undertaken in the empanelled hospitals or at the approved CGHS centres, with all the necessary service documents and costs for processing the claims.

Price Determination

Cost‑benefit analysis or health technology assessment are generally not applied in determining the statutory prices of pharmaceuticals or medical devices in India. Prices are set through market‑based mechanisms under the DPCO or through administrative interventions aimed at affordability and margin control, without reference to cost‑effectiveness metrics.

Reimbursement Decisions

Health Technology Assessments (HTA) have been institutionalised in India through the HTA in India (HTAIn) body to generate proof, although this proof is not yet binding on the NPPA’s pricing decisions. HTAIn, under the Department of Health Research, evaluates the clinical and cost effectiveness of health technologies to inform policy, but there is no statutory requirement for price‑fixing authorities to use its assessments under current law.

In India, the pricing of medicines and medical devices is mainly controlled at the point of manufacture; once an MRP is fixed under the DPCO, no wholesaler, distributor or retailer is allowed to sell the product for anything higher than that price. Therefore, there is relatively limited regulatory emphasis on cost containment at the prescribing and dispensing stages.

In addition, to ensure the affordability of generic drugs, the government of India has taken certain regulatory steps, as follows:

• doctors are ethically required to prescribe medicines by their generic names, and to ensure the rational use of drugs under medical ethics regulations;
• regulatory bodies have the power to take disciplinary action for violations;
• the government promotes affordable generics through Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK), which sell low‑cost generic medicines nationwide; and
• under the National Health Mission, essential generic medicines are provided free of cost in public health facilities, supported by centralised procurement, supply chain systems and prescription audits.

Although the schemes and framework are in place, the enforcement thereof remains a challenge.