Module 1: Regulatory Overview in India

Approval of New Drugs in India

Schedule Y was enacted as per the Government of India notification of 21 September 1988. A new drug can be imported and marketed in Indian under Rule 122A; a new active substance can be imported under Rule 122A for the manufacture of the formulation under Rule 122B/C; a new formulation can be manufactured and marketed under Rule 122B (drugs other than those classified in Schedule C and C1); a new formulation can be manufactured and marketed under Rule 122C (drugs classified as Schedule C and C1); fixed dose combination preparations are regulated by Rule 122D.

Rule 122E defines a ‘new’ drug as one which includes:

  • A new substance of chemical, biological or biotechnological origin; in bulk or prepared dosage form; used for prevention, diagnosis, or treatment of disease in man or animal; which, except during local clinical trials, has not been used in the country to any significant extent; and which, except during local clinical trials, has not been recognized in the country as effective and safe for the proposed claim;
  • A drug already approved by the licensing authority mentioned in rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage forms (including sustained release dosage form) and route of administration;
  • 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, viz. Indications, dosage form (including sustained release dosage form) and route of administration.

Above and beyond these definitions, all vaccines would be considered as new unless certified otherwise by the DCGI.
In India a ‘new’ drug would be considered as ‘new’ for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. This four year stipulation means that all subsequent entrants for a specific ‘new’ drug would need to obtain the approval of the DCGI. Once the four year limit is crossed or the drug is included in the Indian Pharmacopoeia, a drug can be introduced after obtaining the necessary license from the local state food and drug Commissioner’s office. It may be noted that even after getting the approval of the DCGI, one has to obtain the requisite license from the local State Food and Drugs Administration office before marketing the drug.

Having given an overview of the requirements, we now outline some practical issues:

  • Registration of the drug in the country of origin and its status in the United Kingdom and United States of America play an important role in the local registration review.
  • It is not necessary for all applicants to conduct clinical trials if deemed so by the DCGI. Subsequent applicants may be required to conduct bioavailability studies and in vitro dissolution studies to further their application. Registration is not necessarily granted first to the first applicant; if a subsequent applicant has successfully carried out trials and bioavailability studies and has submitted the data before the first applicant and the DCGI finds this data adequate, and then registration can be granted to the subsequent application before the first applicant.
  • Bioequivalence studies are required to be conducted in healthy male volunteers after getting the protocol and center duly approved by the DCGI. The product being tested is to be compared to the innovator formulation or DCGI approved product if innovator is not available internationally.
  • Certain drugs which are specific to special disease areas (e.g., anti-cancer) or novel delivery systems (e.g., transdermal therapeutic systems) may be referred by the DCGI for experts’ opinion (New Drug Advisory Committee) and the product may be cleared based on the experts’ opinion. Such an approval process may be considered by DCGI, based on the medical need and desirability of the product in India. The DCGI selects a list of experts in the field and technical/medical literature is forwarded to the experts who give their feedback directly to the DCGI.
  • Drugs of biotechnological origin would need the approval of the Biotechnology Board in addition to the approval by the DCGI. The DCGI would forward the application for the Board’s opinion.
  • Conduct of Post Marketing Surveillance study (PMS) is a regulatory stipulation. Usually the protocol and centers need to have an approval of the DCGI before initiation of the PMS study.
  • Permission is granted in the generic name along with the approved strengths. As per the current regulatory scenario, generic names are required to be labeled double the size of the trade name. The trade name would appear either below or after the generic name and both names would be in the same type and color scheme.
  • If a drug is permitted for manufacture and for a justified reason, a company cannot manufacture the same drug for some time and if there is a medical need, the DCGI may consider granting the import of a specified quantity of the drug as one time import to tide over the medical need. This procedure is more an exception than a rule and is granted only occasionally for a convincing rationale.
  • Clinical trials can be done on imported formulations; should the application be to import and market, then these studies are acceptable for registration. However, if the application is to manufacture and market, the company would need to formulate the local product and perform bioequivalence studies to be imported formulation. In all likelihood, no trials would need to be conducted with the local formulation. The company can import the active substance to make the local formulation.
  • The first batch of the active substance needs the approval of the Central Drugs Laboratory in Calcutta before it is used for the manufacture the formulation locally. Likewise, the first batch of the imported formulation has to be approved by the same laboratory before marketing.
  • The DCGI has currently been issuing time-bound permissions for two years only. Revalidation of the permission is dependent on conducting the stipulated PMS study and the submission of the data to the DCGI.
  • After the approval by the DCGI, the company would need to obtain the manufacturing license from the concerned local state FDA office. The technical documents on the product as well as administrative / technical documents on the premises need to be furnished in this case.


Dr. Manoj Karwa

Auriga Research Ltd.
Email: [email protected]


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