The Government’s move to keep licensing rights of 17 categories of critical drugs such as vaccines, serum and biological products with itself is likely to be opposed by the State Governments.
Presently, the States have the rights to issue as well cancel licence to the manufacturers of all kind of drugs except blood products.
But, on Thursday, the Union Cabinet gave approval to the Health Ministry’s proposal seeking amendments to the Drugs and Cosmetic Act 2013, which would also empower the Ministry to review or cancel the licence of the pharma firms in case of any violation is reported in manufacturing process of these 17 categories of drugs.
AK Panda, Joint Secretary in the Health Ministry explained that once the Bill is approved by Parliament, the drug manufacturers instead of the State Governments will have to apply to the Ministry to set up the manufacturing facilities in the States.
The Bill is proposed to be brought in the Monsoon Session of the Parliament slated from next month, he said.
However, HG Koshia, Commissioner, Food and Drug Control Administration, Gujarat opposed the move saying that it would centralise the power of functioning.
“In the present set-up too, the State Governments has to take approval from the Drug Controller General of India (DCGI) for the manufacturing facilities,” he said.
However, Panda explained that the move to bring in 17 categories of drugs, mostly biological products such as injectibles, recombinant DNA products, aimed to ensure quality given that manufacturing facilities for such items require huge investment, capability and capacity.
“The Central licencing means only well resourced and manufacturers having adequate expertise come forward to set up such facilities,” he added.
The Bill also proposes to set up a Central Drugs Authority to act as an appellate body for Central and State drug controllers. Besides, it has provisions for setting up the Medical Technical Advisory Board, on the lines of the Drug Technical Advisory Board, to regulate the fast growing medical device industry.
Presently, medical devices are clubbed under the drug category but following amendments, such products will come under separate category. Also, the Bill has the provisions for compensation and penalty issues pertaining to the clinical trial.
Panda said that for the first time there is a provision made for imprisonment of the defaulter drug manufactures in case of wrongs. However, he refused to elaborate details but said that the extent of penalty and imprisonment will depend on the severity of the offence. As per the proposed draft, the term ‘drug inspector’ will be replaced with the drug controller officer.