As many as 23 instances of state licensing authorities (SLAs) granting permissions to fixed dose combinations (FDCs) without prior mandatory approval of the Drugs Controller General of India (DCGI) have come to its notice, according to the Health Ministry.
The Health Ministry also said that the State Drug Controllers were asked to take action under the Drugs and Cosmetics (D&C) Act 1940 in all these 23 cases where licences were granted without the approval of the DCGI.
“The D&C Act, 1940 empowers the state licensing authorities (SLAs) to issue licenses for manufacture and sale of drugs in the country. However, the drugs falling under the category of new drugs require prior approval from the Licensing Authority defined under Rule 21(B) of the Drugs & Cosmetics Rules, 1945 i.e. the Drugs Controller General (India) [DCG(I)] before grant of a licence by the State Licensing Authority,” revealed Union Health Minister Ghulam Nabi Azad in the Parliament recently.
“Further, on 1st October 2012, the Central Government issued directions under sections 33P of the D&C Act, 1940 to all State/UT Governments to instruct their respective drug licensing authorities to abide by the provisions prescribed under the Drugs and Cosmetics Rules in respect of grant of manufacturing licenses for the drugs falling under the definition of the term “New Drug” and not to grant licenses for manufacture for sale or for distribution or for export of such new drugs, except in accordance with the procedure laid down under the said Rules i.e. without prior approval of the DCGI,” he added.
The statutory mechanism of Drugs Consultative Committee provided for in the D&C Act, 1940 ensures regular interaction among the State Drug Control Authorities and the Central drug regulator for uniform implementation of the provisions of the Act and Rules made thereunder. The Drugs and Cosmetics (Amendment) Bill, 2007 introduced in the Rajya Sabha on the 21st August, 2007 already contains the provisions for inter alia creation of a Central Drugs Authority and Centralised Licensing of Drugs, the Minister said.
Recently, the DCGI also issued orders asking the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and made it clear that those FDCs approved by the State licencing authorities from October without the permission of the DCGI will be considered for ban.
Fixing October 1 as the cut-of-date on the vexed issue of FDCs which is still sub-judice, the DCGI directed the state drug controllers to ask the concerned manufacturers to prove the safety and efficacy within 18 months.