Latest news with #RajeevSinghRaghuvanshi
NDTV
27-07-2025
- Health
- NDTV
Centre Flags Carcinogen Fears On Acidity Medicine Ranitidine, Orders Probe
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all state and union territory drug regulators to ensure manufacturers of Ranitidine -- a commonly used acidity medicine --monitor NDMA levels, a potentially cancer-causing impurity, in both the active pharmaceutical ingredient (API) and formulations of the drug. The CDSCO has also suggested reducing the shelf life as a precautionary step. The move comes from the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, following a recommendation by the Drugs Technical Advisory Board (DTAB) during its 92nd meeting on April 28, 2025. The Board reviewed a report submitted by an expert committee constituted in December last year to study the impurity concerns around Ranitidine. Based on this, DTAB has called for a larger committee to examine all aspects of the issue, including storage conditions that may contribute to NDMA formation. In addition, the Board recommended that the Indian Council of Medical Research (ICMR) conduct a study to further assess the long-term safety of Ranitidine in light of NDMA presence. Manufacturers have now been told to adopt risk-based measures, such as limiting shelf life, modifying storage recommendations, and enhancing NDMA testing protocols across their supply chains. "Ranitidine falls in the Group 2A carcinogen category, according to the International Agency for Research on Cancer (IARC), which implies that it is a probable human carcinogen. It should not be continued in prescription when there are safer alternatives such as Famotidine and Pantoprazole available," said Dr Abhishek Shankar, Oncologist, AIIMS Delhi. NDMA is classified as a probable human carcinogen, and its presence in medications has triggered global regulatory scrutiny over recent years. Ranitidine, commonly prescribed for acid reflux and ulcers, was withdrawn from several markets, including the US, after alarmingly high levels of NDMA were found in some samples. "Ranitidine was commonly prescribed in the past. Its usage has reduced in most metro cities, but it is still prescribed in Tier 1 or 2 cities, particularly at primary healthcare centres. In my knowledge, the drug has been known to have NDMA impurities; the FDA has also ruled out the use of this drug in large doses. The DGCI needs to set prescribed limits for NDMA levels in this drug," said Dr Lohit Chauhan, Gastroenterologist at Max Dwarka.
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Business Standard
17-07-2025
- Business
- Business Standard
CDSCO extends COPP application deadline for pharma units to August 15
In an effort to assist pharmaceutical manufacturing units in onboarding the quality certification process, the Central Drugs Standard Control Organisation (CDSCO) has extended the deadline for submitting online applications for a WHO GMP COPP certificate by another month. A Certificate of Pharmaceutical Product (COPP) is issued to confirm that a pharmaceutical product is authorised for sale in its country of origin and manufactured in compliance with Good Manufacturing Practices (GMP). To digitise the process, the apex regulatory body had mandated last month that all manufacturing units submit WHO COPP applications online starting from 15 July 2025. This deadline has now been extended to 15 August. The extension follows reports that several pharma units have encountered difficulties in uploading documents on the government's Online National Drugs Licensing System (ONDLS) portal. In a circular dated 15 July, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi said it had come to the organisation's attention that a number of manufacturers were still in the process of registering and uploading documents on the ONDLS platform. Commenting on the matter, Bhavin Mukund Mehta, vice-chairman of pharma export promotion body Pharmexcil, said many manufacturers—especially small and mid-sized exporters—are still aligning with digital onboarding requirements. The regulatory body had also received multiple representations from industry associations highlighting these onboarding challenges and seeking more time to complete the process. ONDLS is a single-window platform for processing applications such as the issuance of manufacturing and sales licences, GMP certificates, market standing certificates, and post-approval changes—all online. 'The extension will help provide much-needed breathing space to ensure a smooth transition,' Mehta added. Calling digitisation of regulatory processes a step in the right direction for India's pharmaceutical ecosystem, Mehta emphasised that implementation must support ease of compliance while maintaining global standards. The decision also comes at a time when small and medium-sized pharmaceutical manufacturing units—with annual turnover of less than Rs 250 crore—have been requesting a similar extension to submit gap analysis plans required to avail an extension for implementing revised Schedule M guidelines. The CDSCO had earlier instructed all eligible units to submit online applications via ONDLS to seek an extension for compliance with the updated Schedule M norms.
News18
14-07-2025
- Health
- News18
'No Suitable Successor': Govt Defends DCGI's Re-Employment, Says Move Backed By Public Interest
Last Updated: The government said there is no challenge to Raghuvanshi's eligibility and several other petitions, now dismissed as withdrawn, were raised to block the reappointment The Union government has strongly defended its decision to re-employ Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi after his superannuation, calling the legal challenge to the move 'malafide" and 'speculative". The government has asserted that the appointment was made in public interest with the express approval of the Appointments Committee of the Cabinet (ACC). The DCGI heads the Central Drugs Standard Control Organisation (CDSCO)—the country's apex health regulatory authority overseeing the regulation, manufacture, import, export, sale, and distribution of medicines, cosmetics, vaccines, and medical devices. As per an official notification from the Department of Personnel and Training (DoPT) under the Ministry of Personnel, Public Grievances and Pensions, Raghuvanshi has been re-appointed on a contractual basis for one year, effective from March 1, 2025—following his superannuation. The government clarified that this extension would remain in effect until a regular appointment is made or until further orders, whichever is earlier. The re-employment was made by temporarily keeping the recruitment rules in abeyance. However, the decision has been legally challenged for allegedly bypassing established recruitment norms for a position of such critical regulatory importance. In the official response submitted to a writ petition filed in the Madurai High Court, the Centre has questioned the locus standi and alleged that the petition was filed with 'ulterior motives and for extraneous reasons". 'The central government has claimed that the petition is not maintainable and told the court that the allegations of malafides or arbitrariness remain unsubstantiated, and the petitioner has not discharged the burden of proof," a senior official privy to the development told News18, requesting anonymity. Raghuvanshi A 'Distinguished Scientist' The re-employment of the DCGI—a post the government described as holding 'great importance for the Indian pharma market"—was made for a fixed period of one year or until the appointment of a regular incumbent, 'whichever is earlier". The Centre has clarified that the rules were kept in 'abeyance temporarily" and this was permissible under existing DoPT guidelines. The government has noted that there is no challenge to the eligibility of Raghuvanshi and mentioned that several other petitions, now dismissed as withdrawn, were also raised aimed at blocking the reappointment. 'The regular selection process is still ongoing. To maintain regulatory continuity and public health safeguards, the government made a short-term contractual re-employment in the interim," said the official, explaining the contents of the reply submitted to the court. Noting that the post of DCGI is filled via deputation, including short-term contract and not through promotion, the government has clarified that restricting the appointment to promotion would create vested interests in such a 'highly technical and sensitive regulatory post". Raghuvanshi, the Centre's reply stressed, is responsible for the quality, safety, and efficacy of drugs, cosmetics, and medical devices in the country, and also plays a key role in licensing imports, clinical trial approvals, and new drug introductions. Hence, it is the responsibility of the Union government to ensure that the person holding this post has the highest level of qualifications and experience. 'The reply calls Raghuvanshi a distinguished scientist having a credible record and achievements," the official said. In-house officers not suitable The government clarified that the post of DCGI is not a promotional position and is not filled from within the feeder cadre, but through deputation, including short-term contract (ISTC) as per the recruitment rules. It added that officials from within the organisation, provided they meet the eligibility criteria, are also free to apply. The reply explained that in the past, one joint drugs controller had been appointed as DCGI on deputation, while another had held the position on an ad-hoc basis. However, at present, it said, none of the four serving joint drug controllers are considered suitable for regular appointment. 'Two officers do not meet the prescribed eligibility criteria, one is facing prosecution by the CBI under various charges including corruption, and the fourth — who had been posted to Hyderabad due to his wife's medical condition — was on extended leave for over 18 months and is reportedly not attending office regularly." The reply also underscored that exceptional circumstances justified the decision and claimed the appointment was fully within the bounds of law. Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
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Business Standard
08-07-2025
- Business
- Business Standard
MSME pharma firms ask for financial, regulatory help in GMP, NSQ compliance
Several pharmaceutical companies and associations raised concerns over the regulatory and financial issues faced by small and medium units in complying with good manufacturing practices (GMP) during a consultation with NITI Aayog on Monday. According to people in the know, MSME pharma players have asked the drug regulator for Rs 50 crore in handholding support and a further extension for complying with revised Schedule M, which outlines GMP for pharmaceutical units. This request comes after small units with an annual turnover of less than or equal to Rs 250 crore were granted a one-year extension to comply with the revised Schedule M. However, all units under this criterion were required to submit a gap analysis plan to the Central Drugs Standard Control Organisation (CDSCO) by May 30 to qualify for the extension. According to industry insiders, only 1,600 units out of 8,500 MSME pharma units have submitted the plan to the drug regulator. Several groups, such as the Confederation of Indian Pharmaceutical Industry (CIPI), have previously written letters to the CDSCO and the Union Health Secretary, requesting an extension of the deadline for submitting gap analysis plans to August. According to industry sources who attended the meeting, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi stated that there would be no relaxation in the enforcement of GMP. 'He also expressed disappointment with the role of pharma manufacturing associations, urging them to take more responsibility in ensuring that member units uphold quality norms,' an executive added. A group of pharmaceutical associations has also endorsed a GMP-linked support scheme and the establishment of common quality assurance infrastructure for MSME pharma clusters. This comes amid rising concerns over the increase in the number of "Not of Standard Quality" (NSQ) drug alerts. An executive noted that the DCGI outlined a stricter protocol for handling NSQ cases, with companies now facing license suspension after a two-week showcause notice. Reinstatement of such companies will only be considered after a satisfactory Corrective and Preventive Action (CAPA) review. Industry representatives also highlighted the issue of poor educational standards in pharmacy colleges, which may result in technically underqualified personnel unable to handle drug inspectors during audits. Representatives for CIPI also proposed the setting up of financial support for equipping the MSME industry with infrastructure to conduct stability studies, helping to reduce incidents of NSQ. Other issues discussed included quality-linked pricing and procurement, as well as strengthening post-marketing surveillance and pharmacovigilance. Commenting on the issue, Nikkhil K. Masurkar, Chief Executive Officer (CEO) of Mumbai-based Entod Pharmaceuticals, said that NITI Aayog's call for a quality overhaul is both timely and necessary. 'While India has made remarkable strides as a global pharma hub, maintaining consistent, internationally acceptable quality standards remains a key challenge, especially among MSME companies,' he added.
Hindustan Times
21-06-2025
- 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.
