New bill in India proposes single licensing authority to regulate drug manufacture

In a major change towards placing all drug manufacturing responsibilities in the hands of a single licensing authority, the Indian government has proposed that the country's apex drug regulatory body, the CDSCO, (Central Drugs Standard Control Organization), be empowered to regulate the manufacture of drugs and medical devices, instead of state drug regulators as is the current practice.

The CDSCO works under the directorate general of health services, Health Ministry.

In a revised draft of a bill sent for inter-ministerial consultations, the CDSCO is expected to issue manufacturing licences for drugs and cosmetics instead of state regulators, ensuring uniform and effective implementation of the law.