The health ministry’s attempt to make new drug approvals a democratic process seems to have backfired, as the pharmaceutical industry alleges that it has “almost stalled” the drug approval process in the country.
According to 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.
The industry now alleges that the drug regulatory officials are demanding NDAC scrutiny first — and the companies are approaching each member individually for their feedback.
DCGI Surinder Singh was not available for comments. Officials in the drug regulatory department say the new structure had delayed the process, but deny they have stalled the approvals.
According to industry representatives, 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 are not been used on Indian population.
India defines new drugs 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.
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It was in May that the health ministry decided to create a protective layer around the office of the DCGI which was facing criticisms for the way it monitors clinical trials conducted in the country by way of 12 NDACs with 10 members each. The 120 experts were selected from reputed medical schools across the country.
Heads of departments and professors from medical colleges and research centres such as Delhi’s All India Institute of Medical Sciences, Chandigarh’s PGIMER Chandigarh and Mumbai’s KEM Hospital are all part of this committee.
The body’s mandate is to advise DCGI on matters such as evaluation of non-clinical data, preparing guidelines for conduct of clinical trials and identifying the essentiality of such medicines in the context of Indian population.