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New test for generics.

Gandhi

Indian drug regulator slaps stringent rules for licensing generic drugs

The drug controller general of India (DCGI) has asked state drug controllers to check dissolution of generic medicines mainly tablets/capsules in the body through in-vitro test.

This will be done at the time of granting licence to drug companies to check efficacy of generic drugs.

Generic drugs are copy of branded drugs when their patent expires. These drugs are made of sales molecules as branded drugs and are said to be equally effective as branded ones.

“In order to ensure efficacy of generic drugs we have asked state drug controllers to be more stringent before granting licenses,” Dr G N Singh, DCGI told Financial Chronicle.

About 80 per cent of drugs do not dissolve in the body immediately.

Singh added that though India is a leading producer of generic drugs worldwide, regulations and testing in importing companies make drugs more reliable compared with practice followed in India.

About one-fifth of generic drugs produced in the world are made in India and India ranks fourth in terms volume of drugs produced.

About 15 per cent of generic drugs sold in US, world’s biggest drug market comes from India.

Last year, about $13.2 billion worth of medicine were exported from India.

DCGI recently has also got more power in drug trials. Health ministry has notified the rules and procedures for fixing compensation to the victims of clinical trials. The rules notified by the government make DCGI the final authority in the matters relating to the compensation in the cases of serious adverse events like deaths and injuries during the trials.

“New rules will ensure in safety, well being and rights of patients who undergo clinical trials,” said Singh.

The practice allows pharma companies sponsoring clinical trials to recommend compensation amount in case of drug trial-related death or injury.

DCGI will also add more manpower to the regulatory body. “Our aim is to make the Indian drug regulatory system into an efficient and effective regulatory body so as to adopt best patient centric services. We will add 1200 more people in the central drug regulatory system in the next 3-5 years,” said Singh.

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