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New Code for Drug Inspectors
Context:
The Drugs Controller General of India (DCGI) has introduced a new code for drug inspectors across the country to standardise inspections, sample collections, and permit processes, making them more uniform, predictable, and accountable.
About New Codes
- In guideline issued on September 12 to all zonal, sub-zonal, and port offices, drug inspectors have been instructed to follow a standardised method for drug sampling, with a focus on identifying risks while selecting samples of drugs, cosmetics, and medical devices in the supply chain.
- This new code replaces a set of guidelines that had been in place for over a decade, reflecting changes in procedures and advancements in the regulatory system.
- Under the new rules, drug inspectors, in consultation with their authorities, will be required to prepare a monthly and annual sampling plan to finalise sampling locations and cover their entire jurisdiction.
- These plans will include rural areas and drugs used in regions endemic to certain diseases, as well as seasonal medications.
- This approach will improve surveillance of the quality and efficacy of drugs and cosmetics available in the market by adopting a uniform sampling methodology.
- Inspectors will be responsible for collecting samples of drugs, cosmetics, medical devices, and vaccines.
- The guidance also requires drug inspectors to maintain a centralised monthly list of sub-standard or spurious drugs, which will be made public to prevent further use and ensure the availability of genuine products.
- Quick action is to be initiated for non-standard quality (NSQ) products declared by government analysts.
- For uniform enforcement, inspectors must conduct onsite inspections to assess compliance with quality systems and infrastructure, adhering to both national and international Good Manufacturing Practices (GMP) standards.
Drug Regulation in India
Drug regulation in India is primarily governed by the Drugs and Cosmetics Act, 1940, which establishes the framework for the manufacture, distribution, and sale of drugs in the country.
Key Regulatory Bodies:
- Central Drugs Standard Control Organization (CDSCO): This organisation regulates the manufacture, sale, and distribution of drugs and cosmetics.
- Drug Controller General of India (DCGI): The DCGI operates under CDSCO and is tasked with approving new drugs for marketing in India and monitoring their safety and efficacy.
- State Drug Regulatory Authorities (SDRAs): These bodies operate at the state level to implement the provisions of the Drugs and Cosmetics Act and ensure compliance within their jurisdictions.
- National Pharmaceutical Pricing Authority (NPPA): This authority regulates the prices of essential drugs to ensure they remain affordable for the public.