Health Ministry of India soon to amend Schedule K for providing exemption from GMP compliance for export

The Union health ministry will soon amend Schedule K of the Drugs and Cosmetics Rules, 1945. The amendment will 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 discussed on the issue in detail. 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. The manufacture of drugs in the India 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.

As compliance to the additional requirements only add cost and time to the exporters so 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.

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 is 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.