Legislations and Regulations
In addition to the above, there are specific guidelines for various issues, for example, the conduct of clinical trials, market authorisation of bio-similars, rDNA research, ethics and privacy of healthcare-related data.
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, after an inquiry into the matter considered necessary and after giving the appellant an opportunity for making a representation in the matter, make orders in relation to the appeal.
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:
Similarly, the MD Rules provides for a risk-based classification of all medical devices as follows:
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 import 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 for 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.
Procedure for Securing Authorisation to Undertake a Clinical Trial
In order to obtain market authorisation for any of the following, one is required to conduct detailed clinical trials or investigations or performance study as the case may be:
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. The application for drugs discovered, researched, and manufactured in India are 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 accord approval to the clinical trial, bio-availability or bio-equivalence protocol and the related documents and forward its report to the CLA. In case, 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 grants 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 discusses two types of clinical investigations, a pilot study and a pivotal study. A pilot study is an exploratory study which 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 of the Local Clinical Trial in Certain Cases of New or Investigational Drugs
The CLA, with approval from the Central Government, may waive the requirement of the local clinical trial for the approval of a new drug already approved in other countries in the following cases:
Further, the requirements may be relaxed, abbreviated, omitted or deferred in case of life-threatening or serious disease conditions or rare diseases and for drugs intended to be used in the diseases of special relevance to Indian scenario or unmet medical need in India, disaster or special defence use.
The CLA may relax 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 Indian health scenario or for a condition which is unmet need in India, for the 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 the 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 pilot study or to conduct pivotal clinical investigation only.
The clinical investigation may not be required in case of investigation medical devices approved for at least two years in the US, 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.
The trials registered on the 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.
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 bio-logics including the bio-similars are considered as "new drugs" under the DC rules. Therefore, the 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:
In addition, comparative data of the pre-clinical studies and clinical studies of the bio-similars and reference bio-logics are required to be submitted for a bio-similar.
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:
In addition to the CDSCO, the approval of the Biologics is overseen by the following:
An original licence or a renewed licence for manufacture for sale or distribution of drugs to sell drugs unless suspended or cancelled is valid for a period of five years on and 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 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 import 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, import, and export of the medical devices granted under the MD Rules remain 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 the 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 the 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.
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 the 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 are 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 import of which is, otherwise, not allowed.
Small quantities of a new drug or investigational medical device may be imported for treatment of patients suffering from life-threatening diseases, or diseases causing serious permanent disability, or such 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 the specific conditions.
Small quantities of a drug or a medical device, the import of which is otherwise prohibited, may be imported for personal use subject to the specific conditions. Further, the import of small quantities of a drug or a medical donated to a charitable hospital for the treatment of the patients free of cost may be allowed by the CLA.
The holder of the market authorisation for a new drug, an investigational new drug or medical device is under the obligation to conduct Post Market Surveillance (PMS) or phase IV clinical trials. The holder is required to submit the Periodic Safety Update Report (PSUR). The CLA may extend the total duration of submission of the PSUR if it is considered necessary in the interest of public health. The PSUR data is then be 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 form the basis of further decisions about indications/usage/restrictions on indications of the drug or the medical device and further decision on the extension of the duration of submission of the PSUR data.
Currently, 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 offense punishable with imprisonment and/or fine of varying degree based on the seriousness of the offense.
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 import 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 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 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 the drugs and the medical devices are subjected to an authorisation. The CDSCO is the main regulatory body for granting the authorisation.
The DC Rules lays 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 stipulates 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) along with 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 license. 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 establishments engaged in the wholesale of the drugs and medical devices are subjected to an 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 and medical device in question.
A licence issued remains valid if 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.
The DC Act and the DC Rules and the Customs Act, 1962 (the Customs Act) regulates the import and export of the drugs in India. The import and export of the medical devices are regulated by the MD Rules along with the DC Act and the Customs Act. The CDSCO and the Customs are the main regulatory bodies for implementing these legislations and regulations. The CLA grants the licence for import or export.
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 subjected 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 Unauthorised Products.
The import of drugs and medical devices into India is regulated by the CDSCO under the DC Act, the DC Rules and MD Rules as the case may be. Any drug or medical device for which an import licence must be prescribed cannot be imported without one. The DC Act along with the DC Rules and MD Rules lay down the procedure for obtaining the import licence and standards of quality that must be met for the imported drugs and medical devices. Thus, the import 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 MD Rules also stipulate labelling requirements for imported drugs and medical devices. For example, the import of the following is prohibited:
Further, the Central Government has powers to prohibit the import 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 the 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 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 the listed drugs and medical devices. Further, the DPCO stipulates that the government monitors the MRP of all drugs and medical devices including the non-listed drugs and medical devices and ensures that no manufacturer increases the MRP of a drug 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:
According to the NPPA Policy, 2012, the key principles for the regulation of drug price are:
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 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 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 programs 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 provides 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, health care program managers establishing budgets, policy makers making resource allocation decisions, Ministry of Health personnel setting prices, health financing experts looking at resource requirements, researchers, consultants, NGOs and donors.
The prescription of drugs of 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), formulated by the Medical Council of India under the Indian Medical Council Act, 1956 (the IMC Act). The IMC Regulations stipulate that:
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 any medicine prescribed by a medical practitioner.
Currently, there are no specific rules for medical apps.
There are no specific rules for telemedicine in India and a physician can provide medical attention through a mobile device. As per the MCI Act, any person enrolled on the Indian medical register can practise as a medical practitioner in any state of India according to their qualifications. As such, the inter-state practise of telemedicine by medical practitioners is permissible. However, Indian courts have stated that prescriptions should not ordinarily be given to a patient without an in-person examination, except in cases of emergency (Martin F D’Souza . Mohd Ishfaq; (2009) 3 SCC 1).
There are no special rules for the promotion and/or advertising of medicines and medical devices through online portals, company webpages 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 also applies to advertisements relating to drugs.
The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), issued by the Department of Pharmaceuticals, has directions on the information promotional materials for drugs should contain.
The pharmacies can prescribe prescription drugs only on the production of a valid prescription.
Under the Information Technology Act, 2000 (the IT Act), a document that is required by law to be in writing would be deemed to be legal if available in an electronic form and accessible in a way that it can be used for future references. However, the IT Act further states that where the law requires for 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.
Currently, there are no specific rules that govern online sales of drugs and medical devices. The IT Act governs some of the legal issues pertaining to online sales but does not mention anything specific to drugs and medical devices.
In December 2019, the Delhi High Court issued an all-India ban on e-pharmacies, asking online pharmacies to shut down operations by 20 December 2019, and asking the Centre to notify regulations for companies by 31 January 2019. However, within a week the ban was suspended by the Madras High Court on an appeal filed by a group of e-pharmacy companies.
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.
The Electronic Health Record Standards for India, 2016 (the EHRS) issued by the MoHFW provide for standardisation and homogeneity, inter-operability in the capture, storage, transmission & 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" of a person under the Data Protection Rules includes physical, physiological and mental health condition. 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.
A draft bill for Digital Information Security in Healthcare Act (DISHA) is being considered by India. One of the objectives of DISHA is to provide for the privacy, confidentiality, security and standardisation of the electronic health data and provide.
The kind of deal structure fructified between the parties depends upon the objective of the parties and the rationale behind the said collaboration. It could range from an option agreement to a licence agreement or collaboration or co-commercialisation agreements. It is very important for each agreement to explicitly detail specific terms and conditions customary to the transaction.
In case of any disputes between the parties, the agreement should state that the parties aim to resolve their disputes through good faith negotiations. In the event the dispute between the parties cannot be resolved within a stipulated time period (15 or 30 days), only then should the parties aim to resolve their disputes through arbitration. If the parties do proceed towards arbitration, the arbitrability of the dispute, ie, the subject matter of the dispute, should be related to any obligations under the commercial arrangements for the use of the intellectual property. Under Indian law, only disputes relating to rights in personam are arbitrable in nature and any dispute pertaining to rights in rem, for example regarding the validity of the intellectual property which is being licensed, would not be arbitrable.
The parties may mutually appoint one arbitrator who may have expertise in the subject matter of the dispute or appoint an arbitrator each, and their respective arbitrators may appoint a presiding arbitrator. The parties may choose to appoint technical arbitrators each, and the third arbitrator may be an individual with procedural expertise.
India does not have a separate legislation governing mediation. The Supreme Court has formed a committee to draft legislation to give legal sanctity to disputes settled through mediation. Therefore, the dispute resolution clause is recommended to be restricted to having disputes resolved through good faith negotiations and arbitration, prior to litigation.
It is a standard practice to define each party's obligations in terms of the efforts expected to be put in by them, for instance on "commercially reasonable efforts" or "best efforts" basis. Effort clauses are customarily defined to cater to the intricacies of each transaction. The agreement should capture deliverables for each party and the respective timelines for the same. Milestones (if any) should be elucidated upon in the agreement between the parties, along with the respective tasks.
The licence agreement should provide for implications of change in control of either party. A change of control clause may be triggered by a sale of more than 50% of a party's stock, sale of substantially all the assets of a party or a change in most of the board members of a party, etc. As a standard practice, in the event of change in control of either party, certain rights are given to the other party. These rights could be termination rights (providing the counterparty with the right to unilaterally terminate the agreement in such event) and consent rights (the target company may be required to obtain consent from the counterparty). It is very important to analyse the impact of change in control in each transaction and define the rights of the parties specifically in the agreement.
The "consequences of termination" is one of the key terms in a licensing agreement, which is negotiated between the parties. The agreement should expressly state each party’s rights upon termination. This will include clauses regarding return of confidential information, payment of amounts accrued prior to termination, etc. Each party’s rights in the IP, including any data generated under the agreement, must be clearly spelt out in the agreement in order to avoid any ambiguity or dispute regarding respective rights of each party.
Patents are regulated in India under the Patents Act and the Patents Rules, 2003 (the Patents Rules). The most common issue encountered by patent applicants is of 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:
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 constitutes an infringement of a patent:
Defences to Patent Infringement
The Patents Act provides for the following defences to patent infringement:
Further, in any suit for infringement of a patent, every ground on which it may be revoked is available as a ground for defence.
The Patents Act provides for Compulsory Licence (CL) in certain specific circumstances:
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 which 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 counter-claim by the defendant in a suit for infringement.
There are no specific procedures available to a potential generic entrant to establish that what it proposes to do is lawful under patent law. However, any person may institute a suit for a declaration that their use of any process, or their making, use or sale of any article, does not or would not constitute an infringement of a claim of a patent if it is shown that: 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 that the patentee or licensee has refused or neglected to give such an acknowledgment.
There is no patent-linkage in India and, therefore, clearing the way is not a requirement for generic market entry in India.
India has no specific legislation and procedures for dealing with the counterfeiting of drug and medical devices; see 3.9 Border Measures.
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 import 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 the trademark 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 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.