The Union health ministry's attempt to make approvals for new drugs and clinical trials more transparent by constituting 12 New Drug Advisory Committees (NDAC) is proving to be a stumbling block in the way of speedy drug approval process in the country.
The ministry had some time back formed 12 NDACs, comprising experts in the respective fields, to advise the Drugs Controller General of India (DCGI) in matters for review of applications of new drugs and clinical trials.
As per the new structure, DCGI was supposed to take a preliminary look at the clinical trial and other relevant data on the new drugs submitted by companies and then forward it to respective NDAC for expert comments.
Industry sources said that the drug regulatory officials are demanding NDAC scrutiny first, and the companies are approaching each member individually for their feedback. They said that several of the NDAC members have retired during the last six months and nominees have not yet been finalised. Further, there are nominees who are not willing to pass comments on the merit of new drugs that have not been used on Indian population.
New drugs are defined in India as medicines that are not marketed in the country. Even if one company gets to market it, competitors will also have to go through the new drug process for the first few years until the apex drug regulator considers it as an old drug and pass on the responsibility to issue marketing licenses to the state drug authorities.
As per the new structure, each of the panels set up to advise in matters related to review and regulatory approval of clinical trials and new drugs, except for Investigational New Drugs (INDs), relating to different therapeutic areas, has 10 members. The panels were formed on reproductive and urology, cardiovascular and renal, ophthalmology, vaccines, dermatology and allergy, anaesthetics and rheumatology, neurology and psychiatry, pulmonary, oncology and haematology, gastroenterology and hepatology, metabolism and endocrinology, and antimicrobial-antiparasitic-antifungal-antiviral areas.
The committee will advise DCGI in matters to undertake in-depth evaluation of non-clinical data including pharmacological toxicological data, clinical trial data (phase I, II, III, and IV) furnished by the applicant for approval of new drug substances of chemical and biological origin to be introduced first time in the country including vaccines and r-DNA derived products.