Experts demand urgent overhaul of drug regulation policy in India.

Goa Khabar:  Experts demanded an urgent overhaul of the drug regulation policy in India.

Dinesh Thakur, pharma industry whistleblower, Prashant Reddy, lawyer and Ganadhish Kamat, pharma industry consultant who debated the topic, “Drug regulation in India, policies and prescriptions” at the International Centre Goa (ICG) on Saturday lamented the deplorable state of drug regulation in the country.

The experts pointed out that the Indian pharma industry was being governed by the  archaic, Drugs and Cosmetics Act of 1940 and an urgent overhaul was needed to meet modern day demands.

Reddy said, “Drug regulation was a state subject and we have 37 drug regulators in India.This is distorting the drug regulation in the country. Drugs manufactured in one state, are being sold across India, without any system of centralized quality control.”

According to Reddy, a drug like paracetamol was being manufactured in ten, different states and there was no method to check the quality of the same.

Reddy pointed out that the office of the Director Controller General of India (DCGI), the authority appointed to ensure that the Drugs and Cosmetics Act of 1940 was administered properly was often in a disarray. “When a parliament standing committee once inquired about something with the DCGI, the department said the records had been lost. This is how bad the situation is,” pointed out Reddy.

Pointing out the dismal state of clinical trials, Thakur said, “Companies made huge profits by selling the antiviral drug, Fabiflu during Covid. But this was done without conducting adequate clinical trials for the same.”

Kamat lamented the fact that drugs manufactured in India were being blacklisted in some countries. “An Indian cough syrup was banned in Uzbekistan, however there was no punitive action taken against the drug manufacturer in India. Manufacturers must be made to fear the law,” Kamat said.

Reddy also asked for an environment for free and frank dialogue on drug regulation matters. “Today, if you demand a change in policy, you are labeled anti-national!,” Reddy said.

All the experts also felt that an organisartion like the Indian Medical Association (IMA) needed to become proactive and demand proper quality control of drugs.