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Drugmakers may lose product licence if govt labs flag quality failures
The Health Ministry is working with states to allow immediate suspension of licences for drugs declared substandard by labs, following a key recommendation from Drugs Technical Advisory Board
Rimjhim Singh New Delhi
The Ministry of Health is planning strict action against pharmaceutical companies if their medicines fail quality checks. The ministry is in talks with state authorities to allow immediate suspension of licences for drugs found to be 'Not of Standard Quality' (NSQ) by government laboratories, according to a report by The Economic Times.
This move aims to ensure consistent drug quality and safeguard public health, especially after several cases of substandard medicines were reported across the country.
Recommendation of drug advisory board
The proposed action follows the recommendation of the Drugs Technical Advisory Board (DTAB), the apex body advising the Central Drugs Standard Control Organisation (CDSCO). The board, in its recent meeting, underlined the need for quick regulatory intervention once a drug is declared NSQ, the news report said.
'The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufactures. After detailed deliberation, DTAB recommended the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented,' said the minutes of the meeting.
The CDSCO is currently holding discussions with pharmaceutical industry associations, many of which have raised objections to the proposed rule.
'The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification,' said a senior government official, as quoted by The Economic Times.
Pharma industry voices concerns
Pharmaceutical industry representatives argue that NSQ declarations can stem from technical issues rather than deliberate negligence. The Federation of Pharma Entrepreneurs (FOPE) noted in its submission, 'NSQ is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent.'
Industry groups also highlighted potential shortcomings in government laboratory practices. 'This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector,' said a member of one such lobby group, as quoted by The Economic Times.
Industry demands robust review and recall mechanisms
Drugmakers emphasise that rather than immediately suspending licences, the focus should be on strengthening the drug recall mechanism and conducting thorough investigations before action is taken.
FOPE has also called for a detailed impact assessment of the proposed rules. 'We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation,' the group said.
Novo Nordisk launches Wegovy in India
Danish drugmaker Novo Nordisk on Tuesday launched its weight-loss injection Wegovy in India. The once-a-week injectable, already available in the US and Europe, will reach Indian pharmacies by the end of June. Wegovy contains semaglutide, a compound that mimics a natural hormone to help control appetite, reduce cravings, and promote fullness — making it easier for users to adopt healthier habits. Approved for long-term weight management, it also lowers heart-related risks in overweight or obese individuals.
Clinical trials suggest that around one in three users may lose up to 20 per cent of their body weight in just over a year, when combined with diet and exercise. In India, Wegovy is recommended for adults with a BMI of 30 or above, or over 27 with health issues like diabetes or high blood pressure. It is administered once weekly with a pre-filled pen, and the dose increases gradually. Monthly prices range from ₹17,345 to ₹26,015 depending on the dosage.
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