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Hindustan Times
a day ago
- Health
- Hindustan Times
CDSCO flags 186 drugs that fail to meet quality standards
The Central Drugs Standard Control Organisation (CDSCO) has listed at least 186 drugs and formulations as not of standard quality (NSQ) in May , after both central and state testing laboratories across the country flagged these samples, according to the national drugs regulator's alert issued on Friday. CDSCO flags 186 drugs that fail to meet quality standards Two samples were found to be spurious. Data accessed by HT for the year so far, showed that at least 561 samples were labelled as NSQ by the national drugs regulator while three samples were found to be spurious. NSQ drugs are those that fail to meet the quality standards or specifications, including those pertaining to labelling, dissolution, weight uniformity, and sterility. According to a release issued by CDSCO, of the 186 samples that failed the quality test, 128 were identified by various state drugs testing laboratories, while the central drugs laboratories identified 58 . 'As per routine regulatory surveillance activity, the list of Not of Standard Quality (NSQ) and Spurious drugs are being displayed… Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the Govt. Laboratory and it does not warrant any concerns on the other drug products available in the market,'CDSCO said in the statement. 'Two dug samples from the State of Bihar are identified as spurious drugs, which were manufactured by an unauthorized manufacturer using brand name owned by another company, the matter is under investigation and action will be taken as per Act & Rules.' Last year, at least 900 samples were found to be of NSQ and 20 spurious from samples randomly lifted from across the country. As part of the continuous regulatory surveillance, drug samples are picked from sales or distribution points and analysed after which the regulator displays a list of NSQ drugs on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the batches of such drugs identified in the market. The Drugs Controller General of India, Rajeev Singh Raghuvanshi, earlier said that the CDSCO was taking all measures to drastically bring down the percentage of less efficacious drugs, noting that only around 1.5% of the total drugs being sampled were found less efficacious in recent surveys. Identification of drug samples as NSQ is done based on the failure of the drug sample in one or the other specified quality parameters. The regulator said the failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market. Besides NSQs, some defective products related to quality are also categorised as adulterated or spurious drugs, which are considered to have potential to cause serious adverse reactions and even death. 'This action of identifying NSQ and Spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,' read the statement.
India Gazette
6 days ago
- Health
- India Gazette
India hosts 2nd policymakers' forum to strengthen global collaboration on drug standards, access to affordable medicines
New Delhi [India], June 16 (ANI): The Second Policymakers' Forum, aimed at promoting the recognition of the Indian Pharmacopoeia, was inaugurated on Sunday at Sushma Swaraj Bhawan in the national capital. The event was being organised by the Indian Pharmacopoeia Commission (IPC) under the aegis of the Ministry of Health and Family Welfare, in association with the Ministry of External Affairs and in collaboration with India's flagship affordable medicines initiative--the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). The inaugural session was graced by the presence of Minister of State for Health & Family Welfare and Chemicals & Fertilisers, Anupriya Patel, who delivered the keynote address and released a commemorative publication marking IPC's 15-year journey. The gathering was also addressed by Secretary (South), Ministry of External Affairs, Neena Malhotra; Secretary, Health and Family Welfare, Punya Salila Srivastava; Drug Controller General of India and Secretary-cum-Scientific Director, IPC, Dr Rajeev Singh Raghuvanshi; and Advisor (Cost), Ministry of Health & Family Welfare, Rajiv Wadhawan. In her keynote address, Patel emphasised India's commitment to ensuring equitable access to quality-assured medicines and stressed the importance of regulatory harmonisation in facilitating global health equity. She also highlighted that under the visionary leadership of Prime Minister Narendra Modi, India has emerged as a global hub for affordable healthcare solutions and continues to deepen its partnerships with nations through knowledge-sharing, capacity-building, and health diplomacy. The Forum has brought together policymakers and senior drug regulatory officials from 22 countries, including Liberia, Togo, Mali, Mauritania, Sierra Leone, Cameroon, Rwanda, Lesotho, Eswatini, Kenya, Botswana, Ethiopia, Comoros, Seychelles, Madagascar, Papua New Guinea, Zimbabwe, St Lucia, St Vincent & Grenadines, Cuba, Barbados, and Chile, along with two delegates from the Caribbean Public Health Agency (CARPHA), reaffirming India's position as a valued and trusted partner in the realm of global health. This engagement builds on the momentum generated by the First Policymakers' Forum held in August 2024, which resulted in several participating countries formally recognising the Indian Pharmacopoeia as a book of standards for drugs. The growing international interest in aligning with India's regulatory frameworks reflects the credibility and scientific rigour of the Indian Pharmacopoeia, as well as India's proactive role in advancing global public health objectives. Over the course of the four-day programme from June 16 to June 19, delegates will participate in technical sessions covering pharmacopoeial standards, India's regulatory landscape, and successful public health schemes. The technical session on 16th June featured presentations by Dr Rajeev Singh Raghuvanshi, Drug Controller General of India and Secretary-cum-Scientific Director, IPC, on the role and progress of IPC; Dr Ranga Chandrasekhar, Joint Drugs Controller, on the regulatory mechanisms of the Central Drugs Standard Control Organisation; and Ravi Dadhich, CEO of Pharmaceuticals & Medical Devices Bureau of India, on the implementation and impact of PMBJP. In addition, site visits to IPC's state-of-the-art laboratories in Ghaziabad and a Janaushadhi Kendra in Agra, as well as leading pharmaceutical and vaccine manufacturing and R&D facilities in Ahmedabad, have been arranged to provide delegates with first-hand exposure to India's robust scientific and regulatory systems. The Second Policymakers' Forum stands as a platform for building mutual trust, regulatory convergence, and long-term collaboration toward the shared objective of 'Health for All'. (ANI)
Time of India
09-06-2025
- Business
- Time of India
North's science & tech cluster launches ‘Syn-Pharma' to boost pharma innovations in region
Chandigarh: The Northern Region Science & Technology Cluster, PI-RAHI, launched its flagship initiative 'Syn-Pharma' at Panjab University Monday to boost pharmaceutical and MedTech innovation in northern India. The platform aims to foster collaborative research, regulatory support, and stronger industry-academia partnerships. The event was inaugurated by Rajeev Singh Raghuvanshi, Drugs Controller General of India, who said, "Innovation must be guided by quality, not just profit. Value must be in the driver's seat. The next six years are crucial for India to show the world it can deliver affordable, high-quality medicines." Highlighting the growing role of the Chandigarh region in drug manufacturing, he called for deeper collaborations. Renu Vig, PU vice-chancellor and chairperson of PI-RAHI, underlined the role of academic institutions in meeting industrial demands. "Academia has always been keen to bridge the gap with industry. I am heartened by the participation of pharmaceutical companies in Syn-Pharma," she said. Vig stressed the need for innovative research that addresses unsolved challenges in healthcare. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Fischamend: Hansaton sucht 250 Testhörer vor 1972 geboren Hansaton Jetzt anmelden Undo Two major initiatives were unveiled under Syn-Pharma. A Call for Proposals will fund up to Rs 10 lakh for joint research projects between institutions and pharma or MedTech firms. A new industry-oriented PhD programme led by NIPER Mohali was also announced to encourage industrial product development. Three startups mentored by PI-RAHI under PSCST's SHE 3.0 initiative were recognised on the occasion. DACH Biotech Pvt Ltd received Rs 3 lakh for work in cancer diagnostics, Nanokem Innovations got Rs 1.5 lakh for nano-based drug delivery, and Herbspark Nutraceuticals received Rs 2 lakh for herbal therapeutics. The initiative is supported by the office of the principal scientific adviser, CDSCO, and RUSA, with key partners including UIPS, PU, NIPER Mohali, and PSCST.
News18
04-06-2025
- Business
- News18
‘Not A Regulatory Body': Indian Pharmacopoeia Clarifies It Only Sets Standards For Drugs, Doesn't Enforce Them
Last Updated: The clarification comes in the wake of increased global scrutiny of Indian-made drugs The Indian Pharmacopoeia Commission (IPC) has issued a clarification on its role amid growing concerns over impurities in medicines and the quality of drug manufacturing in India, News18 has learnt. In a notice issued by the apex authority titled 'Clarification on impurity limits published in the Indian Pharmacopoeia", it mentions that the IPC 'is in receipt of enquiries from various stakeholders…" and hence, it has been issuing the clarification. The IPC, which is responsible for setting the official quality standards for medicines in India, made it clear that while it defines the standards for impurities in drugs, it is not involved in approving or regulating new medicines. It said that responsibility lies with regulatory bodies like the CDSCO (Central Drugs Standard Control Organisation) and State Licensing Authorities. Both government departments, the Indian Pharmacopoeia Commission (IPC) and the apex regulatory agency, CDSCO, are headed by Dr Rajeev Singh Raghuvanshi. Impurities are small amounts of unwanted substances that may be present in a drug. While some impurities are acceptable within strict limits, their control is crucial to ensure the safety and effectiveness of medicines. The IPC sets impurity limits based on global standards and scientific data submitted by drug manufacturers. These limits are meant to serve as guidelines for making safe medicines, but final approval is always in the hands of the drug regulators. 'The IPC is an autonomous institution under the Ministry of Health & Family Welfare that is solely responsible for setting official drug standards… The IPC does not have any role in the regulatory review and approval of new drugs in India…the CDSCO and/or state licensing authorities are competent to take regulatory decisions." The clarification comes in the wake of increased global scrutiny of Indian-made drugs. Experts had raised questions about whether the IP includes adequate impurity limits for commonly used medicines. However, IPC, in the notice, has reiterated that it works in a consultative and advisory capacity, not as a regulator or certifying body. 'Impurities may be considered by the regulatory authority, provided it is supported with valid scientific justification and relevant data," it said. The notice, signed by Raghuvanshi, also pointed out that 'it is clarified that, in any case, the IPC does not have the mandate to approve or endorse impurity specifications…" Moreover, it added, 'the IPC, being a standard-setting organisation, is also not responsible to express opinion or recommendation in such regulatory matters." In fact, it has asked drug-makers and stakeholders 'to engage with the IPC by submitting scientific evidence to support monograph revisions, wherever required, to promote harmonisation with global standards". First Published: June 04, 2025, 10:26 IST
The Hindu
30-05-2025
- Health
- The Hindu
Need clarity on disposal and return process for cut medicine strips and surgical products: Bangalore Chemists' Association
Welcoming the guidance document on safe disposal of unused and expired drugs released by the Central Drugs Standard Control Organisation (CDSCO) this week, the Bangalore District Chemists and Druggists' Association (BDCDA) has sought clarification on the disposal methods for expired cut strips of medicines and surgical products. Currently, there is no provision for the return and the disposal of these products. The CDSCO's guidance document is aimed at addressing issues emerging from the careless disposal of unused or expired medicines and the hazards it creates in the environment and public health. The document is expected to help various stakeholders, including the general public, to dispose of expired or unused medicine in a safe manner, and is also an important move towards curbing the growth of antimicrobial resistance (AMR). Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a communication dated May 25 to the Drugs Controllers of all States and Union Territories, called on them to encourage the stakeholders concerned in their respective States to adopt the guidelines for safe disposal of expired/unused drugs which will be an important step in combating AMR in the country. The guidance document analyses various methods, including landfill after encapsulation or inertisation of drugs, use of sewer, burning in open containers, medium temperature incineration, novel high temperature incineration, and chemical decomposition. Examining the existing rule position, it details the procedures to be followed by stakeholders for the disposal of such drugs at each level. Need clarity 'Upon reviewing the guidance document, we have identified several areas that require clarification and necessary ratification to ensure the successful and practical implementation of the disposal framework,' said BDCDA president B. Thirunavukkarasu. 'We need clarity on the disposal and return process for cut strips of medicines, for Propaganda-cum-Distribution (PCD) medicines, expired generics where high-trade margins are cited, and expired surgical products such as gloves and syringes. Currently, these are disposed of just like any other trash in the dustbin,' Mr. Thirunavukkarasu said. Elaborating on the operational challenges from a retailer's perspective, he said there is a need to align with the industry practice of 150 days for return of expired medicines presently followed owing to the MoU signed between National Trade body and the pharma companies or provide a flexible period of 60 to 90 days. 'Common batch number mismatches owing to fragmented supply chains must be resolved to avoid denial of returns,' he added.
