n 2022 and 2023, World Health Organisation (WHO) and other regional authorities had issued alerts after several contaminated cough syrups manufactured in India were linked to the deaths of 78 children in Uzbekistan and Gambia.
Recently, the apex drug regulatory body withdrew the power of state licensing authorities to issue clearances to export-only drug manufacturing units. Manu Kaushik explains how this step can bring domestic manufacturing practices in line with global standards
l What are the proposed changes?
THE CENTRAL DRUGS Standard Control Organisation (CDSCO), under the ministry of health and family welfare, has asked the state licensing authorities (SLAs) to stop issuing no objection certificates (NOC) for manufacture of drugs — approved new or unapproved or banned —meant for export, and in fact, hand over all NOCs issued by them between August 2018 and May 2024 to the respective zonal offices of CDSCO. The order, which came into force on May 15, further said that manufacturers can now obtain NOCs from respective zonal offices of CDSCO through its SUGAM portal.
Banned drugs are those that are banned for sale in India but are allowed in the importing country while unapproved drugs are those not yet approved in India but approved elsewhere.
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The regulator has issued the notification to ensure that drugs meant for exports meet the minimum quality standards. In 2022 and 2023, World Health Organisation (WHO) and other regional authorities had issued alerts after several contaminated cough syrups manufactured in India were linked to the deaths of 78 children in Uzbekistan and Gambia.
l What are the key reasons behind this move?
IN AUGUST 2018, the SLAs were delegated the power to issue NOCs to pharmaceutical companies. But it seems that weak enforcement of regulations at the state-level has resulted in this move. It’s believed the SLAs have not been “appropriately” following the protocols which could tarnish the image of India as the “pharmacy of the world”. Experts said the existing infrastructure and manpower resources at SLAs are inadequate to monitor the manufacturing standards. As per government officials, the challenges faced by SLAs are plenty, including ill-equipped testing labs, paucity of drug inspectors, poor understanding of specific rules, patchy surveillance and lack of legal expertise to take action against violators.
l Will this ensure better quality of drugs?
BY KEEPING THE power to approve under its own roof, the central agency can ensure better compliance of the domestic pharmaceutical manufacturing units with international practices. For instance, in January this year, the government revised the Schedule M guidelines to integrate the WHO-GMP (good manufacturing practices) standards. With trained resources and modern infrastructure, the central government is in a better position to ensure better compliance with the revised Schedule M guidelines, experts said. Last year, just about 2,000 out of 10,500 manufacturing units were found to be compliant with WHO-GMP standards. As a key player in the international generic medicine market and with about $250-billion worth of new drugs going off-patent in the coming decade, India needs to spruce up its manufacturing practices to make the most of this opportunity.
l How has the pharma industry reacted to it?
BROADLY, THE INDUSTRY has supported the new rules. “Quality is fundamental for the pharma industry. We welcome this step undertaken by the government to strengthen the quality infrastructure and processes,” said Sudarshan Jain, secretary general at Indian Pharmaceutical Alliance.
Currently, Gujarat, Maharashtra, Himachal Pradesh and Telangana host a major chunk of the country’s pharmaceutical manufacturing hubs, with Gujarat alone having over 30% share in national pharmaceutical production and 28% share in total pharmaceutical exports.
Experts said that the tighter regulations will result in relatively fewer hassles for the Indian exporters who have been repeatedly pulled up by the US FDA (Food and Drug Administration) for production quality issues.
l Steps for better manufacturing practices
OVER THE PAST one year, the department of pharmaceuticals (DoP) has taken several measures to upgrade manufacturing practices, including revamping the pharmaceuticals technology upgradation assistance scheme (PTUAS). Under the revised scheme, the government has expanded the eligibility (for PTUAS) beyond MSMEs to include any pharmaceutical manufacturing unit with a turnover of below Rs 500 crore that requires technology and quality upgradation.
The approach paper on National Pharmaceutical Policy 2023 has also talked about promoting Indian pharmaceutical exports by “upholding high-quality manufacturing standards and compliance with international regulatory requirements.” It now remains to be seen to what extent the latest change can lead to better manufacturing practices in the industry.
