No clinical trials in India for new drugs approved in select developed markets

• Union Ministry of Health and Family Welfare has allowed waivers on conducting trials for new drugs in India in case the drug is approved and marketed in countries specified by — the Central Drugs Standard Control Organisation (CDSCO).

Regulation

• New drugs approved for use in select developed markets will be automatically allowed in India provided global trials included Indian patients.

• This waiver would also extend to drugs that receive these marketing approvals even while a trial is underway in India.

• Data generated (clinical trial) outside the country will be acceptable.

• Providing post-trial access of the drugs to the patients that require it have been defined for the first time.

• It removed a clause in the clinical trials that mandated the sponsor (the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of a patient.

• Now companies will pay the total amount once it is proven that the injury occurred because of the trial.

• Compensations in cases of death and permanent disability, or “other” injuries to a trial participant will be decided by Drug Controller General of India(DCGI).

• It removed regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well-regulated overseas drug markets.

Significance of New Rules

• It will end the unnecessary repetition of trials and speed up the availability of new drugs in the country.

• It will lower the cost of drugs.

• It will improve the ease of doing business for drug makers.

Criticism of new regulations

• India is a country of vast ethnic diversity and most of the trials are done in the West. There is need of bridging trials for ethnically diverse populations to check drug suitability population.

• Waiver should be only for drugs required urgently for
national emergency.

• Proving injury due to the trial is problematic and it is prone to manipulation.

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Mains Paper 2: Health

Prelims level: Central Drugs Standard Control Organisation

Mains level: Read the story

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