Govt waives clinical trial requirement for drugs approved in select countries

Aditi Tandon

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Tribune News Service

New Delhi, August 8

High-end anti-cancer, anti-obesity and anti-rare disorder drugs would soon be available in India with the government deciding to waive local clinical trials for sale of cutting edge medicines approved by six global regulators, including the United States Food and Drug Administration (USFDA).

Covers 5 categories

The waiver only covers five categories — orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defence purposes and new drugs having significant therapeutic advances over the current standard care. This waiver will ensure expeditious availability of the latest medicines.

The Ministry of Health on Thursday made provisions in the New Drugs and Clinical Trials Rules 2019 whereby medicines already approved by drug controllers of the US, UK, Japan, Australia, Canada and the EU, can be sold in India without having to be tested on the local population.

The manufacturers will have to apply to the Indian drug regulator for such market authorisation and the subject experts will have the power to give approvals.

The waiver of local clinical trials will apply to five categories of drugs — orphan drugs for rare diseases; gene and cellular therapies, new drugs used in pandemic situations, new drugs used for special defence purposes and new drugs with significant therapeutic advance over the current available standard care.

At present, medicines, including those approved by stringent global national regulators, are not immediately available in India because of the requirement that they be tested on local population in phase 3 clinical trials on around 200 to 300 people.

The government is often flooded with requests for approvals to such drugs on grounds that their efficacy and safety has already been tested by reputed global regulators as in the west.

“Often, candidates for clinical trials of drugs meant for rare diseases are either not available or such trials take a very long time defeating the purpose of medication. The idea of the waiver is timely availability of cutting edge drugs and new beneficial molecules to Indian patients,” said Drug Controller General of India Rajeev Raghuvanshi.

Asked if the recently USFDA-approved blockbuster weight loss drugs (Ozempic, Wegovy) could also qualify under the waiver, officials said “companies making these drugs would have to prove that they have significantly high therapeutic value over what is available in the market”. Tesla CEO Elon Musk and several Hollywood stars are known to be using the above range of weight loss drugs.

While phase 3 trials (normally done on around 300 people in case of drugs and more in case of vaccines) will be waived, sources said phase 4 trials would be insisted on for the above five categories of drugs also. Phase 4 trials are studies on side effects once drugs have been launched in the market.

Among advantages of the move, officials cited latest medicines to treat a range of cancers, rare diseases like SMA and DMA (spinal muscular atrophy and duchenne muscular dystrophy), autoimmune diseases will become available.

“At present, the delay in launching a new medicine in India is anywhere between five to 20 years as compared to the western markets. With the waiver of Rule 101 in the 2019 law, the scope of parallel launch of medicines in India along with the west will open up,” said an official adding that once a foreign pharma maker’s drug gets market approval in India through the waiver route, local drug firms can collaborate with them for manufacturing and sale.

Sources said the cost of drugs will also reduce with the waiver and there will be substantial reduction in public procurement costs.

Raghuvanshi said the waiver route would also allow India to get access to new antibiotics being developed globally at a time of the growing challenge of antimicrobial resistance.