Govt may introduce Central Drug Authority Bill in Parliament

Govt may introduce Central Drug Authority Bill in Parliament


New Delhi: The Central Drug Authority Bill, providing for a national health regulator, is likely to be introduced in Parliament when it meets after recess in December.

The Bill, which talks of setting up a centralised licensing authority for regulating the healthcare sector, including pharmaceuticals, is presently pending with a Parliamentary Standing Committee on Health and Family Welfare headed by Amar Singh.

“The committee is expected to give its decision on the Bill any time and after that it will be introduced in the Rajya Sabha," Health Secretary Naresh Dayal told PTI.

The Central Drug Authority Bill would also have separate provisions for medical devices, which is at present not differentiated from drugs under the country’s law and it would also have a detailed guideline for regulation of clinical trials industry, Dayal said.

The government is looking to set up a centralised licensing authority across the country to bring uniformity in rules and regulations governing the healthcare sector on the lines of US Food and Drug Administration (USFDA).

It is understood that the Parliamentary Committee has suggested some changes in the proposed draft bill before its introduction in Parliament.

The Bill was referred to the 10-member committee last year. It is also one of the reasons for the deadlock between Health Ministry and Chemicals and Fertilizers Ministry over the National Pharma Policy 2006 proposed by the latter.

Earlier, Mashelkar Committee had also recommended setting up of centralised agency on the USFDA model for effectively regulating healthcare sector in the country.

Health ministry officials have also studied the working of FDA in details before drafting the bill.