The Union health ministry will soon amend Schedule K of the Drugs and Cosmetics Rules, 1945 to make a provision under the Drugs and Cosmetics Rules, 1945 for providing exemption in respect of provisions of Schedule M relating to good manufacturing practices (GMP) in the case of manufacture of drugs for export purposes.
The Drugs Technical Advisory Board (DTAB), the highest authority under the Union health ministry on technical matters, in its meeting held recently deliberated on the issue in detail. After deliberations, the DTAB, based on some conditions, agreed to provide exemption under Schedule K of the Drugs and Cosmetics Rules, 1945 for the manufacture of bulk drug or finished formulations for export only.
The DTAB conditions in this regard read, “The provisions of Chapter IV of the Act and rules thereunder which require the licensee to conform to the provisions of good manufacturing practices as prescribed under Schedule M subject to the condition that the manufacturing facilities have been inspected and registered by the regulatory authorities of the importing country in respect of compliance to the good manufacturing practices for the purpose of import into that country”.
Earlier, in the DTAB meeting held on August 18, 2015, the members were briefed that India is exporting about 56 per cent of its annual production. Ministry of commerce and industry has time and again stated that the manufacture of drugs in the country is required to comply with the conditions of good manufacturing practices prescribed under Schedule M of the Drugs and Cosmetics Rules, 1945 even in cases when the importing country does not require compliance to these requirements, while following international requirements as specified by the importing countries.
Compliance to the additional requirements only add cost and time to the exporters. It has also been stated that even US FDA has specific provisions under their domestic laws for exempting exports from application of domestic laws subject to certain conditions. In order to create ease of business it was recommended by the ministry of commerce to provide a general exemption for manufacture for exports in respect of Schedule M in the cases where the manufacturer is following international requirements as specifying by the importing county.