India: New Drug Approval: Regulatory Scenario In India

Last Updated: 29 March 2016
Article by Pankaj Musyuni

Considering the Indian pharmaceutical industry is the third largest industry in terms of output, it is necessary to understand the regulatory scenario for the pharma sector as the regulations imposed upon them are crucial not only due to essential and stringent regulatory requirements for manufacturing of products such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) but also due to an obligation on regulatory bodies to ensure a healthy supply of safe and quality drugs at an affordable prices to the public.. The branded generics which constitutes about 80 to 85 percent leads the market with a compounded annual growth rate (CAGR) of over 13 % in preceding 5 years and it is expected to grow at a higher rate in near future. The new drug approval in India is now in demand and primary drive of the rules governing approvals of these products is to safeguard public health. Accordingly, it is the role of statutory regulatory authorities to ensure that pharmaceutical companies comply with regulations. Drug approval process can be understood as an optimized procedure by which a new drug molecule is formally approved by drug authority for a person or organization interested to launch a drug product for commercialization. Though an overlook of Indian pharmaceutical Industry shows a complicated regulatory construction wherein pharmaceuticals companies come under the purview of the Ministry of Chemicals & Fertilizers. The Central Drugs Standard Control Organization (CDSCO) which is headed by the DCGI comes under the Ministry of Health and Family Welfare and there is a separate agency for monitoring food products which is the Food Safety and Standards Authority of India. 

Regulatory authority in every country is responsible to implement various rules and regulations for regulating the marketing of drugs. Various stages in process of drug approval include formal administrative requirements for marketing authorization, conducting of clinical trials and surveillance of post-marketing studies. It is worthy to mention here that regulatory capture of matter includes various technical uncertainties in toxicity, safety profile and clinical trials. If any company wants to manufacture, sale, registration and import/export any drug in India, CDSCO is responsible authority for such regulations, which is generally denoted by the title of the head officer, the Drugs Controller General of India (DCGI). The CDSCO ensures safety, efficacy and quality of drugs, cosmetics, diagnostics and medical devices in India. It also regulates marketing, authorization of new drugs, monitoring of clinical trials and also manages drug import and approval license for manufacturing and sale of drug product in territory of India. The new drugs are approved as per the rules and requirements specified in Rule 122A, 122B, 122D, 122E and Schedule Y of Drugs and Cosmetics Rules, 1945. When a company wants to manufacture/import a new drug it has to apply to seek consent from the licensing authority (DCGI) by filing in Form 44 and also submitting the data as given in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945. In order to prove the efficacy and safety of proposed drug molecule in Indian population it has to conduct clinical trials in accordance with the guidelines specified in Schedule Y and submit the report in stated format thereto to the authority.

The prerequisite and comprehensive data to be submitted for application/permission to market a new drug approval application includes chemistry and manufacturing data but not limited to chemical and pharmaceutical information of drug, animal pharmacology/toxicology, human clinical pharmacology, clinical trials which include both exploratory and confirmatory, bioavailability/dissolution and stability data, regulatory status in other countries, marketing information such as proposed product monograph, drafts of packaging information such as labels and cartons, application for test license. However, a provision of exemption is specified in Rule - 122A that the licensing authority may waive certain trials considering the interest of public health and based on the data of the trials done in other countries. For such exemption generally two categories has been adopted. Category A, which includes drugs that have already gained approval by the regulatory bodies in countries as US, Germany, UK, Switzerland, Australia, Japan, South Africa, Europe Canada and for these drugs only phase-III clinical studies are required. Further, under Category B, applications for trials that are not already approved by any recognized regulatory authority are covered and such applications can be submitted at any stage of clinical trials.

With respect to requirement of clinical trial, Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 states that for those drug substances which are discovered in India, all phases of clinical trials are mandatory. Section 2.4 (b) states that for those drug substances which are registered in countries other than India; the applicant must submit the data available from other countries and the licensing authority further may require the applicant to repeat all the studies or permit him to proceed from Phase III clinical trials depending on the discretion. Section 2.8 requires that the licensing authority may require pharmacokinetic studies in terms of bioequivalence so as to show that the data generated in India is equivalent to data generated in foreign countries and then require the applicant to proceed with Phase III trials. Accordingly, the exact requirements of clinical trial depend on a case-to-case basis as to how the safety and efficacy data is sufficient to comply with the regulation.

India is emerging as a significant player in clinical research and pharmaceutical field. The continuous growth and development in regulatory framework is a case in point as to how the pharmaceutical industry is modernising under the rationale of scientific knowledge and public health.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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