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Indian Express
2 days ago
- 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.
Mint
4 days ago
- Business
- Mint
India's drug regulator plans overhaul of Schedule H for prescription medicines
New Delhi: Drugs Controller General of India (DCGI), the country's top drug regulator, is planning a complete overhaul of medicines listed under Schedule H of the Drugs and Cosmetics Rules, 1945, which governs the sale of prescription drugs, said an official aware of the matter and documents reviewed by Mint. Also Read | Key drugs, diagnostics run short in public health centres, govt raises alarm The proposed revamp is driven by concerns, including a rise in antimicrobial resistance (AMR) from self-medication and rampant use of antibiotics purchased over the counter without prescription, the official said. Schedule H includes drugs that cannot be purchased or sold on retail without a doctor's prescription. This overhaul will involve updating the list of prescription drugs by incorporating new medicines and formulations that have been introduced in the market in the recent past. 'The issue related to making suitable reforms in the drug regulatory system has been in discussion for quite some time now. The exercise is part of India's fight against irrational use of antimicrobial medicines, which are used to prevent and treat infectious diseases in humans, animals and plants, including antibiotics, antivirals, antifungals and antiparasitics," said the official on the condition of anonymity. Also Read | What America has got wrong about gender medicine In 2022, a high-level expert committee was constituted by the health ministry to review and revise Schedule H Drugs to recommend comprehensive changes in the drug regulatory regime to reflect global best practices as well as domestic requirements. Remdesivir, dexamethasone, favipiravir, ivermectin and mebrofenin are some of the drugs that are proposed to be added to Schedule H. Right now, there are around 536 drugs under Schedule H. The committee had discussed the existing regulatory framework in detail and noted that the drugs that are not included in Schedule G, H, H1 and X can be easily sold in the country without prescription of a Registered Medical Practitioner (RMP) and it is 'not in public interest", according to the documents reviewed by Mint. Also Read | ICMR gets a breakthrough in attempts to develop first indigenous Nipah virus medicine 'There are many drugs used for various indications like diabetes, TB, heart disease, pain killers etc which are put in special categories like anti-diabetic, anti-pain relief, anti-depressants, anticoagulant drugs, and cardiovascular drugs of the Drug Rule. However, these drugs should fall in schedule H. So, efforts are being made to streamline this," said the official. The expert panel recommended a revamp of the Schedule H. 'Schedule H includes drugs of various categories which require prescription of RMP for their retail sale. The Schedule H needs to be updated regularly to incorporate the new drugs introduced in the market from time to time as well as to review the prescription status of different drugs in the present context. Such regular updates are crucial in the current context to address various regulatory challenges leading to irrational use of drugs, including antibiotics and development of anti-microbial resistance," the documents showed. Wrong or over-use of these medicines can lead to the emergence of antimicrobial resistance (AMR), which is hard to treat and can cause further infections. The committee has proposed more than 700 drugs to be added to the Schedule H drugs list in addition to the existing drugs, as per the documents. The committee also reviewed various aspects of the drugs like their indication, route of administration, international prescription status, abuse or misuse potential, human/ veterinary use, therapeutic/ prophylactic usage etc. When the committee reviewed Schedule G, it opined that drugs mentioned under this list bear caution that 'it is dangerous to take this medicine except under medical supervision". While Schedule G drugs carry a strong caution about medical supervision, the rules governing their sale did not, in the past, explicitly mandate an RMP prescription for every single sale, unlike Schedule H drugs. The committee has recommended the addition of several categories of drugs, namely cardiovascular drugs, neurological drugs, respiratory drugs, anesthetic drugs, antiemetic drugs, immunological drugs, genito-urinary drugs, non-steroidal anti-inflammatory drug, and all sterile formulations of any drug to schedule H.
Fashion Value Chain
27-05-2025
- Business
- Fashion Value Chain
Akums Reports Q4 FY25 with 12.4% Revenue Growth, FY25 Adj. EBITDA Remained Strong at 12.3%
Akums Drugs and Pharmaceuticals Ltd., India's largest contract development and manufacturing organization (CDMO), has announced its consolidated financial results for the quarter and fiscal year ending March 31, 2025. The fourth quarter marked a significant rebound in performance, laying a strong foundation for continued growth and global expansion. In Q4 FY25, Akums reported revenue of Rs.1,073 crore, reflecting a robust 12.4% year-on-year (YoY) growth. The company posted a 10.4% EBITDA margin. Building on its Q4 momentum, Akums closed FY25 with consolidated total income of Rs. 4,170 crore and an adjusted EBITDA margin of 12.3%, a 7-basis point improvement from the previous year. The company continued its focus on enhancing its product mix, building a differentiated, research-driven portfolio, and expanding its global presence. One of the key developments during the fiscal year was securing an approx. €200 million contract for the manufacture and supply of pharmaceutical products to regulated European markets – a milestone that significantly expands Akums' global CDMO footprint. The commercial supplies for this will begin in 2027. To support its expanding footprint, Akums invested Rs. 272 crore in capital expenditure during FY25. which now stands at 49.6 billion units annually. This infrastructure scale-up ensures readiness for large-scale domestic CDMO operations as well as global pharma opportunities. Akums also maintained a strong R&D focus, investing Rs. 130 crore which is over 3% of revenue. With 973 DCGI approvals now, the company's product portfolio has over 4,000 commercialized formulations. This is across multiple therapeutic areas across 60+ dosage forms. Segmental Performance Overview Akums' flagship business, CDMO, contributed ~78% to the group turnover with an adjusted EBITDA of 14.1% in FY 25. The company's domestic branded formulation business segment reported ~9% growth while international branded formulation business grew by ~14%. Trade generics and API segment continue to be in operational loss this fiscal, but the company is taking firm measures to cut the losses in the coming fiscal. Strategic Focus and Future Outlook Despite making meaningful progress across key business segments, Akums reported flat year-on-year revenue, largely due to muted industry volumes and price erosion in APIs. The company, however, continued to invest in long-term growth drivers to consolidate its leadership position in India's pharmaceutical landscape and lay the foundation for global CDMO expansion. With an R&D spend, up 16% from FY24, Akums continues to deepen its innovation capabilities, develop complex formulations, and enrich its portfolio. The company's emphasis on quality-focused manufacturing, novel delivery formats, and patient-centric innovations ensures that its offerings are both globally relevant and therapeutically effective. Commenting on the results, Mr. Sanjeev Jain, Managing Director, said, ' As we look back on the year we got listed, we also look ahead with a renewed sense of purpose. Our entry into Europe is a pivotal step for the Akums' global CDMO expansion. Coupled with strategic capacity expansion and a sharp focus on differentiated offerings, we are laying the foundation for Akums to emerge as a trusted global CDMO. We remain steadfast in our commitment to creating long-term value for all stakeholders and to delivering healthcare solutions that impact lives across geographies.' Mr. Sandeep Jain, Managing Director, added, 'It gives us immense pride to close FY25 on a positive note, especially in a year marked by volatility across the pharmaceutical industry. Despite price erosion in APIs and slowing volumes, Akums remained focused on the fundamentals-operational discipline, innovation, and global ambition. Our new injectable facility is now operational, our R&D engine is stronger than ever, and our differentiated portfolio continues to resonate with partners. These are exciting times, as we accelerate our transformation into a global pharmaceutical manufacturing organization.' Here is the Summary of Profit and Loss Statement for reference P/L (Rs Cr) Q4 FY 25 Q3 FY 25 Q4 FY 24 FY 25 FY 24 Revenue 1,056 1,010 944 4,118 4,178 Other Income 18 15 10 52 34 Total income 1,073 1,025 954 4,170 4,212 COGS 639 602 569 2,433 2,550 Employee Cost 184 176 164 716 647 Other Expenses 139 111 128 508 500 Adj EBITDA 111 136 98 513 515 Adj EBITDA Margin 10.4% 13.3% 10.3% 12.3% 12.2% Depreciation 40 45 34 153 126 Finance Cost 5 5 12 35 51 Exceptional Item -8 -5 0 -17 26 Adj PAT 44 66 46 234 220 Adj PAT Margin 4.1% 6.5% 4.8% 5.6% 5.2%
Mint
23-05-2025
- Health
- Mint
Govt to direct makers of lice lotion lindane on safe use, disposal labelling
New Delhi: The Centre is set to direct manufacturers of lindane, an insecticide used to treat scabies and lice infestations, to put clear labels on the containers to educate consumers about the drug use and its safe disposal, a government official said. The Drug Controller General of India's (DCGI) move follows concerns about lindane misuse in humans. To be sure, lindane is not prohibited in India, and is allowed to be sold as lotion and shampoo for human use. With a domestic production capacity of 1,300 tonnes per annum, India is a major exporter of the drug. Also read: New check for old drugs as Centre reviews safety In January this year, the Union health ministry received a communication from the ministry of environment, forest & climate change regarding lindane, highlighting that Stockholm Convention is a global environmental treaty that aims to protect human health and the environment from persistent organic pollutants (POPs). India is a signatory to the convention. Lindane is listed under the Stockholm Convention on persistent organic pollutants. PoPs are toxic chemicals persist in the environment for long periods, resisting degradation through natural processes. They can remain in the soil, water, and air for years or even decades. They accumulate in living organisms and pose risks to human health and ecosystems. Also read: An influencer gained followers as she documented her weight loss. Then she revealed she was on a GLP-1 The matter was taken up at the Drugs Technical Advisory Board meeting in April chaired by the Director General of Health Services (DGHS). The minutes of the meeting, reviewed by Mint, stated that the board also observed that topical preparation of lindane is used as a second-line treatment for scabies and lice infestations and Stockholm Convention also permits such use. Scabies is a contagious skin condition caused by tiny mites that burrow under the skin, causing intense itching and a rash. Queries sent to the health ministry remained unanswered till press time. In India, lindane formulations are registered for use in pharmaceutical products for control of head lice and scabies on people and sold under different brand names. Also read: Why America has not passed a law to treat addiction better 'Lindane is an affordable and effective drug for the treatment of scabies and lice infestations and recommended for continued marketing of drugs. So, the plan is to issue the guidance note for the manufacturer for safe disposal of the drug at all levels including instruction on the label," said the official aware of the matter. According to the official, unsafe disposal of leftover lindane has led to several cases of accidental misuse in homes.
Mint
19-05-2025
- Business
- Mint
Regulator receives 1,000 applications from MSME drugmakers on good manufacturing practice compliance
New Delhi: The country's top drug regulator, the Drugs Controller General of India (DCGI), has received 1,000 applications from micro, small and medium enterprise (MSME) medicine manufacturers detailing their plans to comply with good manufacturing practices (GMPs), according to two officials in the know. With the application submission deadline ending on 11 May, there was a flurry of applications, given that failure to meet the criteria would result in measures, including show-cause notices, production-halt orders, suspension and even licence cancellation. In 2023, the government notified the revised Schedule M of the Drugs and Cosmetics Act, 1945, to implement GMPs at par with the World Health Organization's (WHO) standards for drug-making companies. Also read | ICMR gets a breakthrough in attempts to develop first indigenous Nipah virus medicine In the first phase, drugmakers with an annual turnover of ₹250 crore and above were to compulsorily follow the GMPs within six months, while the smaller firms were given a year. MSME manufacturers must fully implement the GMPs by 31 December. However, they were supposed to submit a proposal to the Central Licensing Authority by 11 May explaining their upgradation plan. Queries sent to the health ministry spokesperson were not answered till press time. Notably, India is tightening scrutiny in the wake of domestically manufactured medicines failing quality tests overseas due to alleged contamination. For instance, cough syrups manufactured by Indian firms were allegedly linked to the deaths of children in developing countries, including Gambia and Uzbekistan, in 2022 and 2023. The GMP compliance will ensure that drugs manufactured at the domestic plants have safety, quality and efficacy. Global player This assumes importance as the Indian pharmaceutical industry is a significant global player and the largest supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic brands across 60 therapeutic categories. India's pharmaceutical exports stood at $30.47 billion in FY24-25, as per Pharmexcil, a body set up by the government to promote the export of pharma products. The Central Drugs Standard Control Organisation (CDSCO) has developed an online system, the Online National Drugs Licensing System (ONDLS), a portal for drug makers to submit applications. 'The government is mandatorily asking all the pharmaceutical companies to improve their quality. CDSCO has received approximately. 1,000 applications from the firms submitting their upgradation plans. The government is examining the applications now," said the first official. Also read | India tightens export rules for medicines to check wide misuse as narcotics in overseas markets A few days before the 11 May deadline, Union health secretary Punya Salila Srivastava also raised a concern in a review meeting, highlighting that very few firms have submitted their applications to the DCGI. 'However, as per the data available, very few firms have submitted their applications requesting extension of timelines of implementation of revised schedule M," said the health secretary in a letter to the state and Union territory governments. The health secretary directed all the state drug regulators and pharmaceutical manufacturers to take up the issue on priority to comply with GMP within the stipulated time and submit the application for extension on the ONDLS portal. 'We have issued an advisory to companies within our jurisdictions following the directions of the health secretary, " said a drug controller requesting anonymity. Deadline extension 'All the major associations have requested an extension for submitting the application. The deadline of 11 May is over, and those who have given their application will be given an extension to implement GMP by 31 December 2025, and those who did not apply means they have complied with the rules and regulations. Strict actions will be taken against those who are not following the compliance," said the second official. Also read | Govt directs all airports, seaports and land ports to take vector-borne diseases surveillance measures Last year, the Union government introduced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) to help drug makers upgrade their manufacturing units. Under this scheme, the government provides financial aid to firms to upgrade their plants to conform to global standards. Harish Jain, Federation of Pharmaceutical Entrepreneurs, said, 'There are two circumstances: first, a lot of the companies are following GMP compliance, and second, some may not be able to raise the funds and may close down. Multiple reminders have been issued by the governments related to GMP. We also sensitised our member companies to follow GMP." Key takeaways
