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Hindustan Times
28-05-2025
- Health
- Hindustan Times
Haryana tightens noose on illegal abortions: 3 medical shops sealed, 6 FIR's registered in a week
Intensifying crackdown on the illegal sale of medical termination of pregnancy (MTP) kits, Haryana authorities have seized 1,787 kits from seven districts in the last week—May 20-26, tightening surveillance and enforcement to curb misuse of abortion drugs. After the state task force was set up on February 6 to improve Haryana's sex ratio at birth (SRB) under the flagship Beti Bachao-Beti Padhao campaign, authorities have seized about 8,800 MTP kits, registered over 50 FIRs, including at least 18 against online sellers of the kits. As the crackdown is part of Haryana's broader strategy to prevent sex-selective abortions through coordinated monitoring, Food and Drugs Administration (FDA) registered six first information reports (FIRs) in the last week alone, sealed three medical shops, and two medical firms were served notices under the Drug and Cosmetics Rules, 1945, for regulatory violations, according to official data. The violations under the MTP Act are punishable with rigorous imprisonment ranging from two to seven years. These offences are cognisable, non-bailable and non-compoundable. The largest seizure was reported from Yamunanagar, where 1,740 kits were recovered from a distributor operating in Professor Colony. The remaining seizures were made in Gurugram (6), Ambala (1), Palwal (3), Panipat (20), Jind (13), and Rewari (4). 'During inspection at Dezire distributors in Yamunanagar, FDA officials found 1,740 Rule 96 of the Drugs Rules,1945. Of these, 40 kits were taken for testing and analysis, while the rest were sealed,' Manmohan Taneja, state drug controller of Haryana said. 'Prosecution under the Drugs and Cosmetics Act will be launched after following due procedure. The FDA is vigorously going after those involved in this racket of selling MTP kits illegally. Ever since the crackdown was launched, over 50 people have been booked for illegal sale of MTP kits.' As part of the intensified drive, the number of wholesale dealers selling MTP kits has been slashed from 32 to just six within a month. Officials said 373 MTP kits were sold last week to registered MTP centres in the state by six wholesalers, marking a declining trend in the legal sales of these kits. In a parallel enforcement effort during the previous week (May 13–19), the authorities conducted 50 inspections, closed 25 MTP centres, registered three FIRs, and seized 921 MTP kits. Licences of two doctors—one in Kurukshetra and another in Assandh (Karnal)—were suspended for malpractice and guideline violations. To check illegal abortions and protect the rights of the girl child, the additional chief secretary (ACS-health and family welfare) Sudhir Rajpal has also launched a personalised support system. Over 50,000 pregnant women with one or more daughters have been assigned an ASHA or anganwadi worker as a SAHELI (companion) for counselling and close monitoring. Any suspicious abortion in such cases will trigger an investigation and accountability of the SAHELI involved, top government officials said. Meanwhile, on Tuesday, Rajpal reviewed the steps being taken by the STF set up in February to monitor progress achieved in curbing illegal abortions under the flagship 'Beti Bachao-Beti Padhao' campaign. The ACS directed officials to hold senior medical officers accountable in all community health centres (CHOs), ensuring that no illegal abortions occur within their jurisdictions. Henceforth, SMOs will hold weekly meetings with medical officers and CHOs every Tuesday, while chief medical officers were directed to hold meetings with SMOs every Wednesday to review efforts against illegal abortions and improve the sex ratio.
Mint
05-05-2025
- Business
- Mint
Drugmakers to face tougher quality rules: Failed a test? Re-do the exam.
New Delhi: Drugmakers failing random quality checks could potentially be deemed guilty until proven innocent under a fresh crackdown by the government on substandard, spurious and adulterated medicines. The Centre plans to suspend the product permission licence issued to a drugmaker for a particular medicine if even a single batch of that medicine is found to be substandard by any government testing laboratory, said two officials, requesting anonymity. In effect, a drugmaker will not be allowed to continue manufacturing a particular medicine after just withdrawing a failed batch, as is the current practice. India's Drugs Rules, 1945 has no provision on actions to be taken if a batch of medicines fails a quality test, apart from those specific medicines being declared as not-of-standard-quality (NSQ). A drugmaker's licence for that particular drug or product is suspended only if an investigation establishes wrongdoing on the part of the company—an often lengthy process. The Union government's proposed rule changes would also have a bearing on the global pharmaceutical industry. India, which manufactures 60,000 generic brands across 60 therapeutic categories, is the largest global supplier of generic drugs, accounting for about 20% of the global supply. Given the lacuna, state governments resort to ad-hoc actions, and in the process fail to check subpar manufacturing practices that have dented India's image as the 'world's pharmacy". States and union territories are empowered to take action against a drugmaker if a batch of medicines fails a quality check. This includes asking a manufacturer to withdraw a product or suspending the product permission licence if an investigation finds the drugmaker at fault, but these are often not implemented uniformly. 'According to the new plan, once a drug is declared NSQ, the company cannot produce another batch while the investigation is going on, the loopholes are fixed, corrective measures are taken, and regulatory authorities are satisfied with the corrective measures," said one of the officials cited above. 'This is a lengthy process and may take many years." Queries sent to the health ministry spokesperson remained unanswered. Also read | Centre orders thorough safety review of painkiller Nimesulide for adults The Union health ministry will shortly issue a draft notification based on recommendations from India's top drug panel, the Drugs Technical Advisory Board (DTAB), according to the second of the two officials mentioned above. Accordingly, the government plans to amend the Drugs Rules to allow for the immediate suspension of the licence for a medicine that has failed a quality check until the company submits a corrective action and preventive action (CAPA) plan, which has to be approved. All states and union territories will have to follow the new rules, the official said. The suspension on the product licence will only be revoked after a root cause analysis and implementation of corrective measures, according to DTAB's minutes of a meeting on the issue, which Mint has reviewed. 'This is a very important decision taken by the top drug panel," said the first official quoted above. 'Right now, the provision is whenever any drug is identified as NSQ, the licensing authority tells the company that this particular drug batch has failed the quality test, and you (company) withdraw the product from the market. And later an investigation is carried out. In such a case, the manufacturer can go on producing the subsequent batches of the drug. So, there is no restriction on the manufacturer," the official said. Also read | IPC raises concern over five lifesaving drugs for causing adverse reaction The government's plan has come as a shocker to India's $50 billion pharmaceutical industry, which insists that a particular batch of medicines could fail a random test for reasons other than poor quality. 'We respect the DTAB's decision as we understand that they are trying to do something to control NSQ. However, we don't think it is a very good idea to suspend the product permission license as soon as a drug is declared NSQ. There needs to be a thorough investigation before that)," said Dr. Viranchi Shah, national spokesperson for the Indian Drugs Manufacturers Association, which represents more than 1,000 pharmaceutical companies. 'A product can fail due to many reasons such as analytical error, labelling issue, storage or manufacturers issues, or it could be spurious (and may not be manufactured by the original company," Shah said. 'The basic principle to suspend the product permission license is ok until CAPA is done, and we are not against that. However, it should be done with proper checks and balances, and the root cause has to be identified." The government's plan, however, assumes significance considering that 2,988 drug samples were declared to be 'not of standard quality' in 2023-24, and 282 drug samples were found to be spurious or adulterated, according to a response by the government in Parliament. 'Suspending the product permission license is the right thing to do," said Dr. R.V. Ashokan, past president of the Indian Medical Association. 'If a manufacturer cannot ensure the quality of the drug, then they should not do business in this area. Already there is no control on spurious drugs and regulation has failed to stop that. At least in the case of NSQ, the regulatory authorities have the licence with them to control manufacturers." Also read | For small drugmakers playing fast and loose with quality, trouble is on way
News18
01-05-2025
- Health
- News18
Few Pharma Firms Apply For Schedule M Extension After Seeking More Time; Govt Urges Urgent Action
Small and Medium Pharma Manufacturers Association told News18 that firms lack financial resources to upgrade their facilities and government should give them 2-3 years instead of 1 Despite being granted the extension that small and medium drugmakers had asked for, most pharmaceutical companies have still not applied to delay compliance with Schedule M or revised drug manufacturing rules, News18 has learnt. The central government has shown concern over the trend and asked firms to act quickly. Quality concerns Following allegations levelled over the quality of made-in-India drugs by multiple countries, including the World Health Organization, in 2023, the central government updated the Good Manufacturing Practices (GMP) under Schedule M of the Drugs Rules, 1945. Many micro, small, and medium-sized (MSME) drug companies — those with a turnover of less than Rs 250 crore — asked for more time to meet these new standards, as the move requires both investment and time. Considering the industry's request, the government issued a new order in February 2025, allowing eligible companies to apply for an extension until December 31, 2025. To get this extension, companies had to submit an application and a plan for upgrading their facilities within three months. However, according to the letter seen by News18, Punya Salila Srivastava, secretary at the union ministry of health and family welfare, despite this support and multiple reminders—including official letters and a review meeting at the Central Drugs Standard Control Organisation (CDSCO)—very few companies have applied. ' … as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the letter, dated April 30. Srivastava, who has sent the letter to the health secretaries, special chief secretaries, and principal secretaries of all states and union territories, has now asked state drug regulators and industry associations to take this matter seriously. 'It is requested to issue necessary directions to the state drug regulators and pharmaceutical manufacturers in your state/UT to take up the issue on priority … within the stipulated time and submit the application for extension on the ONDLS portal," the letter said. The union health secretary has highlighted that compliance with revised drug laws is 'critical" for the quality and safety of medicines manufactured in India. 'By taking necessary action together, I am sure we can ensure safety, quality and efficacy of drugs. To this effect, compliance with the necessary provisions of the Revised Good Manufacturing Practices (GMP) under Schedule-M is critical," she said in the letter. Handholding, financial support and more time needed: Pharma association Nipun Jain, chairman, Small and Medium Pharma Manufacturers Association, told News18, 'Small and medium pharmaceutical companies lack the financial resources to upgrade their facilities to meet the new standards. Rather than pushing us out of business in the name of aligning with global norms, the government should support and guide us through training and assistance to help us meet these standards. We request that the government reconsider the decision to extend the deadline to two to three years, along with extending financial support to the industry." He referred to the letter written by his association in January, which urged the health ministry for a 'condition-free" timeframe of two to three years for implementing Schedule M. Similarly, RSS affiliate Laghu Udyog Bharati (LUB) told News18 that the demand for an extension of the deadline was extended when their lobby requested the union health minister JP Nadda. 'On the request of Laghu Udyog Bharati, Hon'ble Health Minister JP Nadda extended the implementation of Revised schedule M guidelines up to 31st Dec 2025 for below 250 crore turnover MSME companies," said LUB in a statement. However, Ghanshyam Ojha, all-India president of LUB, said, 'We demanded a blanket extension as every small company has to invest Rs 4 crore to Rs 10 crore in plant upgradation for Revised Schedule M certifications." Ojha mentioned how drugmakers are struggling with the 'gap analysis of every plant" and facing technical difficulties in several steps. 'Small and medium enterprises are in panic and are trying hard to comply with new norms," he said while adding that the drugmakers will request the union health ministry to consider their request to give the industry more time. According to government data, there are around 10,500 manufacturing units in the country, of which at least 8,500 are in the category of micro, small, and medium enterprises (MSME). Of these, 2,000 are approved by the World Health Organization certified as WHO-GMP (Good Manufacturing Practices). tags : drug manufacturing medicine Location : New Delhi, India, India First Published: May 01, 2025, 17:58 IST News india Few Pharma Firms Apply For Schedule M Extension After Seeking More Time; Govt Urges Urgent Action
News18
24-04-2025
- Health
- News18
Paracetamol, Ibuprofen May Soon Be Available At General Stores As India Reviews First List Of OTC Drugs
Last Updated: A committee has proposed that India needs to develop legal provisions, eligibility for considering drug as OTC and special labelling similar to those for prescription medicines A total of 27 prescription-only medicines, including levocetrizine, ibuprofen and paracetamol will soon be sold at medical and general stores as over-the-counter (OTC) drugs, News18 has learnt. The list of 27 drugs includes the names of generic formulations and the strength of doses allowed to be sold without a prescription. Currently, India lacks a comprehensive set of regulations governing the distribution, marketing, and consumption of OTC drugs. In May, drug regulator Central Drugs Standard Control Organisation (CDSCO) constituted a sub-committee to examine matters regarding the amendment of the Drugs Rules to incorporate necessary provisions for drugs to be declared as over-the-counter (OTC), in line with a recommendation of the Drugs Technical Advisory Board (DTAB) meeting. Now, the panel has submitted the report, and DTAB will deliberate to move on moving forward. 'The subcommittee has finely balanced and submitted the report containing almost 27 generic names of formulations for the top therapeutic segment. These formulations are top-selling and best in the safety profile of that category. For instance, Levocetirizine is best to treat allergies, ibuprofen is best for painkillers and paracetamol for anti-pyretic use," a senior official at the Ministry of Health and Family Welfare, privy to the development, told News18. The sub-panel has also mentioned the strength of the medicines which should be available in the OTC category. 'It would be damaging if people end up popping painkiller ibuprofen in higher doses. Hence, the idea is to keep the moderate or mild dose available without prescription." 'Legal provisions to be enabled under Drugs Rules, 1945 along with the manner of submitting application, requirements for considering a drug as an OTC, Labelling requirements, etc and incorporation of a separate Schedule as enumerated under section 7 of the report," said the government document containing agenda for discussion on upcoming DTAB meeting. The DTAB meeting is expected to convene in April. However, the final decision may take several meetings as the central government needs to design a full plan before it decides to shift prescription medicines into the OTC category. The sub-committee was headed by Dr Anupam Prakash, Director and Professor of Medicine, Lady Hardinge Medical College, Delhi. The panel has other members including as Dr Umesh D Suranagi from Director General of Health Services (DGHS), Paediatrician Dr Ratan Kumar Gupta from Vardhman Mahavir Medical College & Safdarjung Hospital and Dr Bikash Medhi, Department of Pharmacology, Post Graduate Institute of Medical Education & Research (PGIMER).
