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Economic Times
30-07-2025
- Health
- Economic Times
Monitor presence of potentially carcinogenic chemical in Ranitidine: DCGI to drug controllers
New Delhi: Drug regulator DCGI has asked drug controllers of all states and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical -- N-Nitrosodimethylamine -- in antacid Ranitidine. Ranitidine is used to reduce the amount of acid the stomach makes and also in the treatment of acid reflux and stomach or intestinal ulcers among issue related to safety of Ranitidine drug due to presence of N-Nitrosodimethylamine (NDMA) impurity has been under consideration for quite some time now and various measures have been taken from time to time, the Drugs Controller General of India (DCGI) said in a communication on July 24. An expert-committee was constituted in December last year and the report of the expert committee was placed before the 92nd Drugs Technical Advisory Board (DTAB) meeting in April this year, the communication, which also had minutes of the DTAB meeting as enclosures, said. The communication said DTAB, after detailed deliberation, recommended that a larger committee is required to be constituted which will look into all the aspects, including the storage conditions of Ranitidine. Also it suggested that the Indian Council of Medical Research (ICMR) may conduct a study for assessing the safety of Ranitidine drug considering the presence of NDMA impurity. "The manufacturers should monitor the NDMA levels in the API/formulation and also take risk based measures such as reducing the shelf life etc," the communication said. "In view of above, as recommended by DTAB, you are requested to direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life etc," it added.
Mint
09-07-2025
- Health
- Mint
From factory to pharmacy: Will new transit rules ensure safer drugs?
New Delhi: India is working on new rules to ensure that medicines purchased by customers are safe and haven't lost their efficacy during transit from manufacturing units to the pharmacies. Proposed new guidelines also call for clear traceability rules for everyone handling these medicines, starting from their origin to their user, to prevent spurious and substandard drugs entering the supply chain, said two government officials aware of the development. Currently, the rules are lax about storage during transit and are not mandatory, leading to concerns about their quality. A special committee, chaired by India's apex drugs regulator—Drugs Controller General of India (DCGI)—met recently and discussed the draft rules. These propose that each stage of packaging must have printed 2D barcodes along with legible text containing important details including the unique product code (GTIN), batch number, expiry date, manufacturing date, and a serial number. This will help track medicines through their transit journey. In addition, every entity handling the transportation must record details of the product, receivers and senders, and the time and place of transaction. This comes in the backdrop of the Central Drugs Standard Control Organization (CDSCO) developing a comprehensive national action plan to combat substandard and spurious medical products in the country as reported by Mint earlier. There have also been instances when medicines meant for hospitals (marked "not for retail sale") have been mixed with regular pharmacy stocks, amid complaints about expired or damaged products. 'The Drug Consultative Committee (DCC) in its meeting last month discussed an important issue of drug storage during transit. It was noted that current guidelines aren't mandatory, which means drug manufacturers aren't consistently ensuring proper storage conditions until the products reach wholesale and retail levels. To address this, a draft guideline has been prepared, aligning with updated WHO (World Health Organization) standards. However, the proposed guideline needs to be discussed with stakeholders including the drug manufacturers and distributors before any final decisions are made," said one of the government officials cited above requesting anonymity. The proposed rules call for Good Storage Distribution Practices (GSDP) that are essential to ensure the quality, safety, and efficacy of medicines throughout the supply chain from the manufacturer to the end-consumer. Medicines are sensitive products that can degrade due to improper storage, exposure to extreme temperatures, or mishandling during transit. GSDP also helps in stopping fake and substandard drugs from getting into the market, and allows for tracking. 'Right now, these crucial guidelines aren't a mandatory part of the Drugs Rule, 1945. Therefore, the plan is to put good storage and distribution practices in the Drugs Rule, thereby making them a legal requirement for everyone involved, including drug manufacturers, distributors, and retailers. This will ensure that medicines maintain their quality and effectiveness across the entire supply chain. A draft notification will be issued to make this provision legal, once things are finalised," said the second official cited above who also did not want to be named. The development assumes significance given that India's pharmaceutical market is valued at $50 billion and is ranked the third-largest by volume and 14th by value. India is the largest global supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic drugs across 60 therapeutic categories. Queries emailed to the spokespersons of the health ministry and DCGI remained unanswered till press time. Rajiv Singhal, General Secretary of All India Organization of Chemists and Druggists (AIOCD), which says it represents about 1.2 million chemists and distributors across India, said that everyone involved has an important role to play. 'Wholesalers and distributors also need to report any suspicious or fake drugs. They need to store medicines properly. Pharmacies and chemists should also store drugs as recommended, check their quality and expiry dates before selling them, keep good records of sales and purchase, and educate the patients on how to use and store medicines safely," Singhal said. Manufacturers say the Centre's initiative to introduce mandatory 2D barcoding and comprehensive traceability across the pharmaceutical supply chain is a much-needed step. 'It will go a long way in tackling issues like counterfeiting, pilferage, and improper storage during transit. More importantly, it will create a culture of accountability across every stakeholder, from manufacturers to distributors to retailers. While there may be some implementation challenges for smaller players, the long-term gains in patient safety, quality assurance, and global confidence in Indian pharma far outweigh the short-term hurdles," said Entod Pharmaceuticals chief executive officer Nikkhil K. Masurkar. 'We view drug delivery as a critical extension of our commitment to quality and patient safety. Ensuring that medicines are transported and handled under controlled, compliant conditions is as important as how they are manufactured. We've invested in robust cold-chain systems, GPS-enabled tracking, and tamper-evident packaging to maintain product integrity throughout the supply chain. Drug delivery is not just about logistics, it's a matter of public health," added Masurkar, whose company manufacturers medicines such as specializing in ophthalmology, ENT (ear, nose, and throat), and dermatology.
Time of India
08-07-2025
- Business
- Time of India
Pharma lobby flags 'cumbersome' export rule, seeks change
New Delhi: A significant dip in exports has prompted pharma lobby groups to raise a demand for changing the centralised no-object certification (NOC) provision for drug exports . The provision, which requires pharma companies to seek an approval from the national regulatory agency of the importing country or an NOC from the Indian regulator for shipments, has resulted in a drop in exports and diverted trade to other nations, industry executives told ET. The issue was raised in a meeting held on Monday at Niti Aayog . "Pharma exports have suffered due to the mismatch or an anomaly in newly introduced regulatory standards by the drug regulatory authority of India," said a person who attended the meeting. In early March, the Drugs Controller General of India (DCGI) updated the export NOC checklist in the wake of events such as the controversy over a Mumbai-based drugmaker allegedly exporting addictive opioid drugs to West African nations such as Ghana and Nigeria. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like What the Market May Be Getting Wrong About Nvidia Seeking Alpha Read More Undo However, the stringent norms have started hurting exports, industry insiders said. "Taking approvals from different regulatory bodies has only made the whole process cumbersome," the person cited above said. He noted that medicines are manufactured depending on the patient population construct. Live Events For example, Dolo and other paracetamol tablets are approved in India in strengths of 325mg, 500 mg and 650 mg while in Nigeria, it's approved for a strength of 1,000 mg. To manufacture and export that, Indian drugmakers now require an NOC from Nigerian authorities. The lobby groups have urged the government to review the provision as, according to them, this would divert trade to other nations with less stringent regulations. "Such a condition has imposed an undue burden on Indian exporters, potentially stifling innovation and hindering the export of unapproved/banned products especially for the MSME pharmaceutical sector, which is under tremendous strain with respect to compliance to domestic and international guidelines and trade barriers (tariffs & non-tariffs),' an industry expert said on condition of anonymity. The Niti Aayog had called pharma experts to undertake an analysis of the current state of the industry, to understand the challenges faced by drugmakers and initiatives taken by them to ensure production of safe and effective products. Nikkhil K Masurkar, chief executive of Entod Pharmaceuticals, said the official think tank'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 said. "The root of the problem often lies not in intent, but in outdated infrastructure, fragmented regulatory enforcement, and insufficient technical training," Masurkar said. "To produce world-class medicines, we must invest in continuous quality improvement, digitalise compliance systems, and empower our MSME sector with both financial and technical support."
Economic Times
02-07-2025
- Health
- Economic Times
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
Time of India
02-07-2025
- Health
- Time of India
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three months. The order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three months. However a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same grounds. The court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in question. Live Events Notably, Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making Ozempic. Victoza (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and obesity. Legal experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight management. The PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism. Fitness-tech entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it said. The drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
