Latest news with #DrugsandCosmeticsRules
News18
3 days ago
- Health
- News18
Small Drugmakers Supplying Medicines In Rural Areas Under Scrutiny; Centre Calls For Crackdown
Central Drugs Standard Control Organisation has conducted over 1,000 Risk-Based Inspections across the country and asked states/UTs to continue acting after finding non-compliance. Small pharmaceutical companies, especially those supplying medicines in rural areas, have come under regulatory scrutiny, with the Drug Controller General of India (DCGI) directing state officials to closely monitor their activities and ensure accountability. The DCGI has asked states, via state licensing authorities (SLAs) to take strict action against any such marketers found violating quality standards under the Drugs and Cosmetics Rules, 1945. The move comes amid growing concerns over the quality and compliance practices of certain small-scale players in the drug distribution chain. The apex drug regulatory agency has also called for stricter action against the repeated manufacture of spurious and Not of Standard Quality (NSQ) drugs and asked states to keep CDSCO informed of any regulatory actions taken. 'We are still awaiting response on Schedule M compliance and most small players are unable to cope up with quality scrutiny. The government is convinced that without proper oversight, these companies pose a risk to medicine safety in under-served regions," a senior government official privy to the development told News18. The official added that the apex regulatory authority, Central Drugs Standard Control Organisation (CDSCO) has conducted over 1,000 Risk-Based Inspections (RBIs) across the country. 'These inspections have been key in identifying non-compliance among drug manufacturers and strengthening the surveillance framework." The first is adoption of revised Schedule M. The DCGI has asked state officials to begin enforcing updated Good Manufacturing Practice norms for drug production units. Also, it has asked to fix new drug licensing gaps as state licensing officials have been asked to refrain from issuing product licences without proper permissions from DCGI. The officials have also been instructed 'Post risk based inspections action." The states and UTs have been urged to act on the findings and recommendations that emerge from inspections. CDSCO has informed officials to comply with '84AB" in which details of all drug makers and product details must be uploaded and verified on the central online portal to ensure traceability. Also, the state officials will work on building testing lab capacity which has been flagged as a 'critical need."
Mint
4 days ago
- Health
- Mint
Bigger fonts, clearer tags: How the drug regulator is looking to redesign hard-to-read medicine labels
New Delhi: Ever squinted at a medicine strip trying to find the expiry date, or popped a pill without knowing whether it's branded or generic? You're not alone. India's top drug regulator is stepping in to change that. The Drug Controller General of India (DCGI) is working on a nationwide overhaul of medicine packaging and labelling norms. The goal is to make expiry dates and batch numbers easier to read, reduce confusion between generic and branded drugs, and help patients, make better-informed choices, two government officials aware of the matter said. As part of the proposed changes, manufacturers may soon be required to use larger fonts, ditch shiny packaging that reflects light and obscures print, and print expiry dates in more than one place to prevent vital information from being torn off. There's also a plan to introduce a universal symbol to clearly distinguish generic medicines from branded ones. The regulator had received several complaints regarding the difficulty in differentiating between cheaper generic drugs and their branded counterparts, and consequently, the pricing comparison. "The drug regulator has received various complaints and demands from the consumers regarding the labelling of medicinal products such as tiny font size of the letters printed on the drug packaging, shiny labels, the expiry date of the medicines getting torn while taking out the medicine, and demand for universally recognised symbol on the generic medicines that will distinguish it from the branded medicines," said one of the officials cited above requesting anonymity. A sub-committee, set up by the DCGI, is reviewing the proposals and is expected to submit its report soon, the second official said. The committee is also examining ways to incorporate these changes under the Drugs and Cosmetics Rules, 1945, which governs the quality of drugs manufactured, imported, and sold in the country. Queries sent to the health ministry on Monday and DCGI spokesperson on Tuesday remained unanswered till press time. Also Read: India's drug regulator plans overhaul of Schedule H for prescription medicines Branded vs generic While both generic and branded medicines contain the same active ingredient and are expected to have the same therapeutic effect, their key differences lie in cost, brand recognition, and patent status. Branded medicines such as a well-known painkiller, often carry a higher price tag due to the research, development, and extensive marketing by the innovator company. Generic medicines, on the other hand, are typically much cheaper (often 80-85% less) because they are manufactured after the original drug's patent expires, eliminating the need for costly R&D and marketing. For instance, if 'PainRelief Pro' is a popular branded drug for headaches, its generic equivalent, say 'Paracetamol 500mg', will offer the same relief at a fraction of the cost. But customers often miss this. They ask for affordable, quality medicines but are often unaware of generic alternatives, said Rajiv Singhal, president and General Secretary of the All India Organization of Chemists and Druggists (AIOCD) representing 1.2 million members in the country. He called for expiry and batch details to be printed in clearer, larger fonts in multiple places to prevent accidental torn off. 'If this regulation comes into play, companies will have to mandatorily follow," he said, emphasizing the importance of regulatory enforcement. The development assumes significance given that India holds the distinction of being the world's largest supplier of generic drugs, accounting for approximately 20% of the global supply and manufacturing around 60,000 generic brands across 60 therapeutic categories. Mint had earlier reported that DCGI was considering Braille labelling on drug packaging to support the 4.95 million blind and 70 million visually impaired people in India. Global standards Globally, drug labels tend to be much simpler. Dr. Viranchi Shah, national spokesperson for the Indian Drugs Manufacturers Association (IDMA), said Indian medicine strips are detailed compared to their international counterparts. For example, international labels often only state the tablet's name, omitting details like coating information or the explicit phrase "to be sold on the prescription of registered medical practitioners." Instead, the "Rx" symbol is commonly used to indicate a prescription requirement, with its absence signifying an over-the-counter (OTC) drug. The extensive information and specific font size requirements on Indian labels are seen as cumbersome, leading to substantial inventory costs and a significant financial burden on companies for redesigning packaging, Shah said. He said that the industry is open to changes for the greater good and informed that IDMA had previously submitted its representation to the DCGI years ago, suggesting simplified labelling. He said that a key hurdle to such changes is the significant inventory held by pharmaceutical companies. Changes to labelling would require a phased approach to avoid disruption. 'Any future changes, whenever and however implemented, should consider suggestions from both patients and the industry, and be introduced in a phased manner to minimize disruption." This step will empower patients and enhance transparency in the Indian pharmaceutical market, said Nikkhil K. Masurkar, CEO, Entod Pharmaceuticals. The current lack of visual cues on packaging, he said, often leaves patients unaware of generic alternatives. The government's Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) may also benefit from the labelling overhaul. PMBJP operates over 17,000 Janaushadhi Kendras across India to offer quality generic medicines at affordable rates. Also Read: Centre orders thorough safety review of painkiller Nimesulide for adults India's pharmaceutical market, meanwhile, continues to expand. According to Pharmarack, the Indian Pharmaceutical Market (IPM) reached ₹19,720 crore in sales for May 2025, showing a 7.2% YoY growth. On a moving annual total (MAT) basis, the industry posted ₹2.29 trillion, reflecting an 8.1% annual growth and 9.8% CAGR. While pharma companies may face some logistical costs in updating their packaging, the industry believes these are manageable and worth the impact on patient safety, affordability, and transparency.
Time of India
5 days ago
- Health
- Time of India
15 pharmacies lose licences in Niuland for norms violations
Dimapur: State Drugs Control Administration (SDCA) has cancelled the licences of 15 pharmacies in Niuland district of Nagaland for failing to meet regulatory requirements. As part of efforts to enforce the Drugs and Cosmetics Act, 1940, and its associated rules, a joint inspection was conducted on Tuesday by a team comprising the Niuland district administration, police, and officials from Dimapur chief medical officer's office. Tired of too many ads? go ad free now The team was led by assistant drugs controller Martemjen Longkumer and drugs control officer Boto Sema. As per an official order issued by the SDCA, the licences were revoked due to non-compliance with earlier showcause notices. The pharmacies were found to have violated Rule 65(2) of the Drugs and Cosmetics Rules, 1945, and Section 42 of the Pharmacy Act, 1948. Health and family welfare minister P Paiwang Konyak earlier directed the SDCA to shut down all pharmacies operating without valid registration, licences, or qualified pharmacists. This action follows a statewide crackdown on unlicensed pharmacies. In April, authorities cancelled the licences of 54 pharmacies in Mokokchung town, and in Feb, licences of 24 pharmacies were revoked in Dimapur and Chümoukedima districts for similar violations.
Hindustan Times
20-06-2025
- Health
- Hindustan Times
Nagaland pharmacy association appeals to state govt for policy review claiming pharmacist shortage
Kohima, The All Nagaland Pharmacy Association has urged the state government to reconsider the strict enforcement of rules mandating registered pharmacists in all pharmacies, warning that the move could lead to widespread closures and disrupt healthcare access across Nagaland. At a press conference in Kohima on Friday, ANPA president Zhapuvilie Yashü and general secretary Limayanger Jamir said that although they respect and are willing to comply with the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and Pharmacy Act, 1948, the shortage of qualified pharmacists makes full implementation currently unfeasible. Quoting official data that there are 1,157 licensed pharmacies in Nagaland, Jamir claimed the state has only 278 registered pharmacists, of which, 252 are employed in government facilities, leaving just 26 for private pharmacies. Several districts, including Shamator and Meluri, have no registered pharmacists at all. Phek district, with 34 pharmacies, has only two while even in Kohima, some localities could be left without a single pharmacy if the rule is strictly enforced, he said. "This ratio is grossly disproportionate. Enforcing the rule without practical alternatives will throw the public health system into disarray," Jamir warned. ANPA said the licensing process has long been regulated by the Health & Family Welfare department, with pharmacies regularly paying fees. However, in late 2021, the department began enforcing stricter requirements for pharmacist appointments, it said. Yashu said while some private pharmacies have appointed pharmacists, most cannot do so due to the acute shortage. To address the issue collectively, pharmacy unions were formed in every district and unified under ANPA on March 13 this year, he said. ANPA said that despite repeated appeals to the Principal Director, Health Commissioner, and Health Minister, the association said their requests for a phased implementation or temporary relaxation have not been addressed while a representation to the chief minister is still pending. "If enforced fully, even key areas in Kohima and several districts will be left without pharmacy services," ANPA said. Pointing out that Nagaland is currently the only state in India without a pharmacy institute, ANPA said that even in other states, full enforcement of such policies has been hindered by manpower shortages. They questioned the government's expectations, noting that many government health centres rely on nurses trained for only three months to dispense medicines. "If the government can authorise nurses due to shortages, similar temporary measures should be extended to pharmacies until infrastructure is improved," ANPA argued. While the Drugs Control Administration had renewed licenses until 2028, pharmacies have recently begun receiving show cause notices and cancellation orders from May onwards, they said. ANPA clarified it is not opposing the policy but asking for a practical, state-specific approach that protects public health without disrupting essential services. "Until we have sufficient manpower and our own pharmacy institutions, we request the department to allow pharmacies to continue operating," the association appealed. They assured that if granted a reasonable extension, efforts to appoint registered pharmacists would continue. Meanwhile, Tiatoshi Amer, Controlling & Licensing Authority under the Health & Family Welfare Department, told PTI that the department acted only after repeated notices went unheeded. "We issued public notices and also verbally informed licensees to appoint pharmacists for the welfare of the public," he said. Amer added that the department will not consider an extension as enough time had already been provided, emphasising that public health remains the department's top priority. The officer also asserted that, as per data provided by the department's Pharmacy Cell, there are more than 300 registered unemployed pharmacists in the state, while for the government health units, the vacant posts are being requisitioned annually through the Nagaland Public Service Commission for recruitment.
Indian Express
06-06-2025
- Health
- Indian Express
India has to maintain global regulatory standards to remain the pharmacy of the world: Ex DCGI
Former Drugs Controller General of India (DCGI) Dr G N Singh, who is now the Advisor to Uttar Pradesh Chief Minister Yogi Adityanath, was leading an outreach programme in Gujarat for pharmaceutical companies to set up units of the Bulk Drug Pharma Park coming up in Lalitpur district. He spoke to The Indian Express on the sidelines of the country's need to maintain global scientific standards and regulation. Dr Singh also served as the Central Drug Standards Control Organisation (CDSCO) for six years till 2018, and as the Founder-Director of the Indian Pharmacopeia Commission (IPC). Excerpts from the interview: How do you see the development and future of the pharmaceutical manufacturing sector in India? India wants to become self reliant in manufacturing and innovation in bulk drugs. That is why the Prime Minister, over the last few years, has given special emphasis on developing pharma parks across the country. In this context, the UP Chief Minister decided to develop a bulk drug park in his state. And we want to make sure that if any international incident happens, since the geopolitical situation is in a troublesome phase, then we can be self-reliant. In such cases, India has to be ready to address issues like healthcare. We (India) are known as the pharmacy of the world since we supply medicines to more than 200 countries. So we have to see that the continuity of supply of medicines remains undisturbed. When you talk about the geopolitical situation, are you referring to the excessive imports of Active Pharmaceutical Ingredients (APIs) from China? Majority of our APIs are being imported from China. It is the thinking of experts at the highest level that India has to be fully self-reliant. We are, but due to cost prohibition, we were lacking in API production. Now with bulk drug parks coming up, the cost of production will also come down and we will become competitive in the international market and hopefully begin supplying APIs to many others, especially Europe and other developed markets. We will capture those markets based on quality, prices and uninterrupted supply. There have been complaints coming in from many nations, including Africa and Europe and ones flagged by the USFDA, regarding the quality of drugs going out from India. How do you see this in context of the way 'made-in-India' medicines are perceived abroad? As scientific systems are developing, the regulatory landscape is also changing. We are continuously adjusting the regulatory system so that the regulator meets the expectations of scientific rigour and the people. Safety, efficacy and quality of medicines is of paramount importance to the regulator and to end users everywhere. So, we want to make a harmonised approach so none of the issues lag behind the science requirements. Both the Drugs and Cosmetics Rules and the Indian Pharmacopeia (IP), which is the book of standards for drugs, are continously being upgraded to address these issues. So, does the Indian drug regulator need more teeth? Is stricter regulation required today? The requirement is to strengthen the drug regulatory system in terms of science, in terms of manpower, in terms of the execution of mechanism and the government must be thinking on those lines because it is aware of these issues. If we want to remain the pharmacy of the world we need to maintain the standards of global science and regulation. The most recent debate is regarding generic drugs. There have been problems highlighted with regards to bioequivalence studies and doctors are pushing back against compulsorily prescribing them. How do you see this issue? It is only a myth. These issues have been raised multiple times and as a scientist, I am of the firm opinion that the book of standards is the same for branded, branded-generic or generic medication. If you take the Indian, US and UK Pharmacopeias, they are not ascribing different standards. They are all the same — right from manufacturing systems, quality control and testing before batches reach the market. So, I don't agree that generic drugs are in any way less than the branded medicines and it is just a myth with no basis in scientific parameters. They are almost equal in my opinion and I had made it very clear on various forums, including international ones, not just as a former drug regulator of this country, but also as the head of the Indian Pharmacopeia Commission. I appeal to the doctors and to the people to accept generic medicines as ones at par with the branded ones.
