DCGI issues fresh code for drug inspectors to keep market vigil

New Delhi: The Drugs Controller General of India (DCGI) has issued a new code for drug inspectors posted across the country to make their inspections, sample collections and permits uniform, predictable and accountable.

In a guidance issued on 12 September to all zonal, sub-zonal and port offices, the drug regulator directed drug inspectors to follow a uniform drug sampling method and focus on identifying risks during selection of sample drugs, cosmetics and medical devices moving in the supply chain.

Old guidelines replaced

The new code replaces a more-than-decade-old set of guidelines in view of changes in the procedure and advancements in the regulatory system.

As per the new set of rules, each drug inspector in consultation with their authority shall prepare a sampling plan on a monthly and annual basis for finalizing the sampling locations to cover the entire jurisdiction. The sampling plan shall include rural areas and drugs used in areas endemic for certain diseases, drugs for seasonal diseases etc.

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This will be useful for effective surveillance for quality and efficacy of drugs and cosmetic available in the market by adopting uniform drug sampling methodology. Inspector will have to collect samples of  drugs, cosmetics, medical devices and vaccines.

Drugs are regulated under the Drugs & Cosmetic Act, 1940 to ensure safety, efficacy and quality of the drugs available in the country.

Centralized list

According to the guidance note, the drug inspectors will have to maintain a centralized monthly list of sub-standard or spurious drug and put it in public domain to avoid their further use and ensure the availability of true product in the market and initiate quick actions for NSQ product declared by the Government Analyst.

For conducting uniform enforcement, the drug inspectors have to do onsite inspections to evaluate compliance of the quality system and infrastructure with nationally & internationally accepted Good Manufacturing Practices (GMP) Standards. However, the inspection will have to be conducted in the knowledge of manufacturer with proper evidence and documents.

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Notably, DCGI is the head of Central Drugs Standard Control Organization (CDSCO) which has 8 Zonal offices, 7 Sub-Zonal offices, 8 Central Drugs Testing Laboratories and 9 Airport & 19 Sea port Offices.

Last year, Parliament was informed that the number of sanctioned posts and filling of the vacant post of Drug Inspectors in the states come under the respective State Government. Such information is not maintained centrally. However, CDSCO, till December last year, has 504 sanctioned posts, 201 is working strength and 303 are still vacant post.

Shortage of drug inspectors

This indicates that there is a major shortage of drug inspectors in CDSCO and at the level of state government. 

“There’s an acute shortage of competent medical devices officers at CDSCO and State Licensing Authorities from the Engineering and science background to adequately regulate medical devices that have recently came under regulations. Due to these shortages pharmacists drug inspectors have been redesignated as Medical Devices Officers and in many cases these are not experts at the diverse range of engineered medical devices they are supposed to regulate. This becomes a huge challenge to manufacturers as they struggle to communicate with these regulators who see products like Defibrilator and ventilators from eye of a medicine . It’s like an airforce officer trying to insist on a naval officer what’s expected by the Airforce," explained Rajiv Nath, forum Coordinator, AiMeD ( Association of Indian Medical Devices Industry adding that the government needs to address this issue urgently. 

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Queries sent to the health ministry spokesperson remained unanswered.