Experts concerned over govt’s move to grant marketing approval for drugs without clinical trials

Nandita Vijay, BengaluruTuesday, August 8, 2017, 08:00 Hrs  [IST]

Union government is toying with the idea to permit approvals of clinical trials data for drugs approved in the global market for India.

According to a media report, the government sees that the move could possibly bring down the time to approve and market drugs from a period of around 7 years to a mere 45 days. The proposal is expected to discontinue conducting global trials for India.

The proposed suggestion is expected to enable faster access to drugs for patients in the country and save cost of clinical studies too.

Commenting on the development, Dr Dhivya Ashok Kumar, consultant, surgeon and head R&D, Dr Agarwal’s Eye Hospital, Chennai, said that the government’s new policy to stop local clinical trials on proven drugs can affect healthcare to certain extent. There are few drugs which need to be tested in Indian population as it has racial differences from western population.

“Moreover in eye care, especially in topical formulations whose effect may depend on the bioavailability of the drug in the particular ocular tissue for example the eye pigment layers in Indians is high. There are also different disease patterns like the tuberculosis etiology, common in India. Hence few proven drugs with known effect in other races may also require individual assessment in local population. On the other hand, if the existing drug is seen to have an additional new indication and has shown good therapeutic effect in few patients; only a proper clinical trial can confirm this. Additionally, the microbial growth and drug resistance also varies from geographical locations, said Dr Kumar.

According to Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka state drugs controller, just because the clinical trial is done in some other developed country it does not means that that drug suits for Indian population. However I feel waiver of clinical trial should be decided by DCGI on case -to- case basis considering all aspects. DCGI will need to take appropriate steps in the interest of Indian population, pointed out Dr. Jagashetty.

Kaushik Desai, pharma consult is of the view that government’s proposal is good for those drugs like infectious diseases like tuberculosis, typhoid, malaria, Hepatitis or even for cancer and pain management. But the western data of clinical trials just cannot hold good for lifestyle disorders like cardiovascular and diabetes. In these conditions, Indian clinical trial data is much wanted because it based on the genetic predisposition. There should be some minimum criteria including review of post marketing surveillance data for new drugs. However this initiative will have positive impact on access to new drugs on needy patients.

Now coming to the fixed dose combinations where efficacy is already proven in India, the government should look into it and provide a status because a decision in this is much desired for the industry, noted Desai.

It is imperative that any new drug to a new population needs to undergo a specific study. Genetic make-up, susceptibility or resistance and associated habits cannot be certainly ruled out. Also factors like drug-to-drug interactions specific to that population play a vital role when it comes to dosages and administration, said Dr Sashi Kiran Kode, managing director, D2L Pharma Research Solutions.