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Business Standard
7 days ago
- Health
- Business Standard
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.
Time of India
25-06-2025
- Health
- Time of India
Pharma companies may lose licence if drugs fail tests
Drugmakers will have to face strict government action if their products fail quality parameters and are declared as substandard. The punitive measure is being proposed by the health ministry during ongoing discussions with states to ensure quality drug production and safeguard public health. The ministry is looking to issue a notification shortly that will mandate immediate suspension of product licences of companies found producing 'not of standard quality' (NSQ) drugs by government laboratories, officials said. The Central Drugs Standard Control Organisation ( CDSCO ) on its part has been deliberating the matter with pharma lobby groups that have raised objections. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Victoria Principal Is Almost 75, See Her Now Reportingly Undo Earlier, the government's technical advisory board on drugs, which is part of CDSCO, had approved taking swift action against such manufacturers. Live Events "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 for 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," according to the minutes of a board meeting of the technical advisory body. "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 government official on the condition of anonymity. However, the pharma lobby groups have raised objections and given representations. NSQ, "is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent," the Federation of Pharma Entrepreneurs (FOPE) said in its representation. In a recent meeting, pharma lobby groups also pointed out that many government testing laboratories are facing challenges in following the current standards. "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," a member of a lobby group opined. "It has been found that in many cases, samples declared NSQ by government labs, when challenged and tested by CDL Kolkata, have been declared as Standard Quality by CDL Kolkata, which is an appellate laboratory," the person said. Drug makers also emphasised that more than suspending licenses, it is crucial to strengthen the "recall mechanism". FOPE urged a proper impact analysis given the sensitivity of the matter. "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 lobby group said.
Mint
20-06-2025
- Health
- Mint
Drug regulator pushes for Braille labelling on medicines
New Delhi: India's top drug regulator is evaluating a plan for Braille labelling on medicine packaging to improve accessibility for India's 4.95 million blind and 70 million visually impaired citizens, who struggle to identify crucial medication details, said an official aware of the matter and documents reviewed by Mint. The Drugs Controller General of India (DCGI) is considering these changes based on a report of a subcommittee that recommended introducing Braille labelling for drugs packaged in mono cartons and for those frequently used by the visually impaired, such as eye drops. 'Currently, there is no labelling provision in the Drugs and Cosmetics Act and Rules that considers the needs of blind or visually impaired people," the panel recommended. 'As a result, this special category of people finds it difficult to know the name and expiry date of medicines. Therefore, a provision should be made to label drugs with Braille inscriptions." The recommendations stem from a 2020 representation highlighting the difficulties visually-impaired individuals faced when trying to read medicine strips. The subcommittee was first constituted in 2020 and then reconstituted in October 2024 under KR Chawal, Drug Controller and Licensing Authority of Delhi, along with three more members. Also read: Which private hospital is best for you? New grading system will help patients decide on treatment options An added benefit The committee report also said that Braille labelling will help combat counterfeit drugs. 'Braille fonts on drug pack labels are unique and difficult to copy, which could significantly reduce the incidence of drug duplication and spurious products in the market," according to the documents of the 66th Drugs Consultative Meeting (DCC) reviewed by Mint. India's spurious or counterfeit medicine drug sales are valued at $3 billion. The country's overall medicine market is currently valued at $50 billion, with domestic consumption at $23.5 billion, according to the department of pharmaceuticals. Queries emailed to the spokespersons of the health and family ministry and the DCGI remained unanswered till press time. Voluntary rollout, initially The subcommittee's recommendations presented to the Drugs Consultative Committee (DCC) on 17 June are currently under consideration to make the implementation voluntary or mandatory to start with through legislative amendments to the Drug Rules, 1945," said the official aware of the matter, requesting anonymity. "Initially, it has been proposed on a voluntary basis because people (drug makers) would take time to switch over to Braille labelling. We also have to see how the Indian industry is going to adapt to change. That is why it is being proposed for additional labelling in Braille language to be implemented 'initially on a voluntary basis' for drugs supplied in mono carton pack sizes," the official said. To ensure the accuracy of Braille labels, the subcommittee's report has recommended that drug manufacturers have their Braille artwork validated by nodal agencies such as the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID) through the Braille Council of India (BCI) or other NIEPID-recommended bodies. Also read: Centre moves to enhance organ transplant services in govt hospitals after review shows capacity constraints The report has excluded Braille labelling for medicines and other pharmaceutical items dispensed under direct healthcare professional supervision, including injectables and vaccines. Also, the report recommends that the competent authority issue an advisory to retailers, instructing them to verbally guide visually impaired customers about medicine names, dosage, indications, uses, and expiry dates. This guidance would be routinely monitored by enforcement officers. 'Putting Braille labelling on drug making is a good idea. Even if a 1% population gets benefits, it's worth doing, especially for life-saving drugs which are of significant use, and not just limiting it to certain eye drops," said Dr. J.S. Titiyal, head of Dr. Aggarwal's Eye Institute in New Delhi and former chief of RP Eye Centre at the All India Institute of Medical Sciences. He said that visually impaired individuals may have other health complications beyond eye issues. Dr. Manipal S. Sachdeva, chairman and managing director at Centre for Sight, said Braille labelling should be on all kinds of important life-saving medicines, not just eye drops. But he expressed reservations about making it a voluntary requirement. 'We don't know how the voluntary initiative will be picked up by the manufacturers, because it will add to their expense and logistic issues." Also read: Centre orders thorough safety review of painkiller Nimesulide for adults
Time of India
14-05-2025
- Health
- Time of India
Govt may mandate QR codes on vaccines, key drugs to curb counterfeits
New Delhi: Vaccines , antimicrobials, narcotic drugs and psychotropic substances, and additional cancer drugs would have to mandatorily print or affix bar codes or quick response (QR) codes on their labels. This follows the government mulling the possibility of bringing them under Schedule H2 of Drug Rules to track their movement to curb counterfeiting. Additionally, the government is considering inclusion of details of excipients on every medicine strip for 300 drug formulations that are under Schedule H2. Currently, the labels declare only those active substances added in the formulation. An excipient is a constituent of a medicine other than the active substances, added in the formulation for a specific purpose. While most excipients are considered inactive, some can have a known action or effect in certain circumstances. "The Drug Controller General of India (DCGI) will hold a meeting this week to deliberate on both the issues," people in the know told ET. Earlier the drug regulatory authority had included a few cancer drugs to help validate the authenticity of medicines following incidents of refilling of expensive anti-cancer drugs with counterfeit drugs . It came to light that criminals in collusion with hospital pharmacies were found refilling empty vials of expensive anti-cancer medicines with counterfeit drugs. These fake drugs were then mixed with genuine stocks and sold to unsuspecting cancer patients, putting their lives at risk. Live Events In a bid to weed out spurious drugs, the regulator had made it mandatory for companies to have a barcode on the top 300 brands, so that information such as manufacturing licence and batch number can be accessed upon scanning. These drugs included widely-used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets.
