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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.
Time of India
18-05-2025
- Business
- Time of India
In a first, state regulatory authority warns Ayurvedic drug making firm
1 2 3 4 Kozhikode: In a first-of-its-kind move in the country, regulatory authorities in the state have acted against a prominent Ayurvedic drug manufacturer for violating Rule 170 of the Drugs and Cosmetics Rules, 1945, which is meant to prevent misleading advertisements. Acting on a complaint filed by ophthalmologist and RTI activist Dr K V Babu on Feb 11, the Kerala deputy drugs controller (Ayurveda) carried out an investigation and subsequently issued a stern warning to Pankajakasthuri Herbals India Pvt Ltd for alleged violation of Rule 170 which mandates that manufacturers obtain prior approval from state licensing authorities before advertising their products. The drugs controller stated that any further violation could result in stringent measures against the firm, including withdrawal of the medicine's production licence. The investigation revealed that the company had not obtained approval for the advertisement issued for Orthoherb tablet published in a Malayalam daily on Jan 9. Pankajakasthuri Herbals had in its explanation to the drugs controller said that it had withdrawn the said advertisements and assured that it would issue advertisements in future only after obtaining prior approval. Rule 170 of the Drugs and Cosmetics Rules, 1945, is designed to prevent misleading advertisements for Ayurvedic, Siddha and Unani (AYUSH) drugs. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Cost Of Amusement Park Equipment From Mexico Might Surprise You - See Tips Amusement Park Equipment | search ads Click Here Undo Specifically, it requires manufacturers to obtain prior approval from state licensing authorities before advertising their products. Dr Babu said the action taken by the deputy drugs controller (Ayurveda) was significant as it was for the first time in the country that action was taken on a complaint regarding Rule 170 after the rule was reinstated by the Supreme Court on Aug 27, 2024. Though Rule 170 was gazetted by the govt on Dec 24, 2018, it was stayed by the Delhi and Bombay high courts in 2019 and later omitted by the central govt.
Mint
02-05-2025
- Health
- Mint
Centre orders thorough safety review of painkiller Nimesulide for adults
New Delhi: Concerned over the rampant misuse of Nimesulide drug used to treat pain and fever, the government has asked the Indian Council of Medical Research (ICMR) to conduct an extensive review of the prescription medicine and its effects on adults. Nimesulide is classified as a Schedule H drug under the Drugs and Cosmetics Rules, 1945. Drugs listed under Schedule H are prescription drugs, which means they can only be sold by retail on the prescription of a registered medical practitioner. Also Read | Side-effects of banned drug Nimesulide still reported in children: Report India's top medical research body will review this drug after it was withdrawn or had its use curtailed in several countries due to safety concerns. Recently, India completely banned this formulation for veterinary use due to safety concerns. 'There is a concern that Nimesulide drug may be causing side-effects to adults as well. To review the same, it has been referred to the ICMR. Right now, there is only one medicine—Paracetamol—to reduce fever, which reduces temperatures by 2 degrees. So, there's no alternative. Now, the government is evaluating the effects of Nimesulide in adult population. The drug is already banned for paediatric use for children below 12 years," an official aware of the matter said. Queries sent to a Union health ministry spokesperson remained unanswered till press time. Also Read | Pharmacy colleges being rated after teaching scandal Nimesulide belongs to a class of painkillers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), widely used for its anti-inflammatory properties. The drug is easily available over the counter. Introduced in the early 1980s, it quickly became popular for its fast-acting and effective relief of various pain and inflammatory conditions. Experts say that prolonged use of Nimesulide can adversely affect liver and kidney, and can also interfere with fertility. In India, the use of Nimesulide is prohibited in children below 12 years of age, following reports of liver damage. Also Read | India seeks details of pharma exports to Pakistan ahead of likely total ban Recent concerns have been raised regarding its continued use among adults, especially in high-risk groups, prompting the Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI), to review the safety of the drug. The issue was discussed at a Drugs Technical Advisory Board (DTAB) meeting held in the Union ministry of health and family welfare last week. 'ICMR has been asked to conduct a systematic review of the use of the drug in adult population for further deliberation to take a final call," the official cited earlier said on the condition of anonymity. Nimesulide is available in India under different brand names manufactured by several companies. In India, Dr. Reddy's Laboratories is among drugmakers that produce Nimesulide. A Dr. Reddy's Laboratories' spokesperson said: "Robust research and clinical trials have consistently established the safety and efficacy of Nimesulide, when used as prescribed. We respect the ICMR's recommendations regarding Nimesulide. We wish to clarify that our company does not manufacture or distribute Nimesulide in doses exceeding 100 mg. Our Prescribing Information (PI) for Nimesulide serves as a comprehensive guide for healthcare providers, ensuring responsible prescription and use of the medication. The PI specifies that Nimesulide is indicated for short-term treatment in approved indications, and not exceeding more than 10 days. Additionally, the PI highlights that Nimesulide is not recommended for use in pregnant or lactating women and patients with renal or hepatic impairments." To be sure, in 2023, a representative from Dr. Reddy's Laboratories submitted a representation to DCGI highlighting the safety of Nimesulide in adult population. According to PharmaTrac data, the drug's Moving Annual Total (MAT) for sales, which represents the total sales value over the past 12 months, has grown by almost 15% since 2020 and currently stands at ₹ 424 crore. During last week's DTAB meeting, ICMR said that that Nimesulide should be used only as a second-line drug, after exhausting first-line options, the official said. At the meeting, ICMR said that Nimesulide should not be used in pregnant, lactating and women planning for pregnancy. 'Nimesulide should not be used in patients with renal and hepatic impairment and also should not be co-administered with other hepatotoxic and renal toxic drugs." All oral formulations of Nimesulide above 100mg in immediate release dosage form should be prohibited, it said. Medical experts said that Nimesulide needs to be used cautiously, and dose should not exceed 100mg. Dr. Arvind Aggarwal, senior consultant, internal medicine, Sri Balaji Action Medical Institute, Delhi, said: 'Nimesulide is a Schedule H drug in India and requires a prescription, but it is widely available over the counter (OTC). Self-medication is the main concern which is increasing the risk of adverse effects. Prolonged use of Nimesulide can adversely affect liver and kidney, can also cause fertility issues. Hepatotoxicity or liver toxicity is the most widely observed side-effect of Nimesulide. The drug is banned for children under 12 due to severe liver damage risks." He added that some European countries have restricted its use to short-term only, and consider as a second-line therapy if other drugs fail. However, in India, doctors are using it as a first-line treatment. 'Hence, a regulatory concern is justified given the risk factors. The safety review of Nimesulide would lead us towards effective patient safety in terms of medicine use and surely reassess its role in adults, particularly in high-risk groups."
The Hindu
22-04-2025
- The Hindu
Medical store owner, peddler arrested after addictive painkiller leads to death of teen
Two persons, including a medical store owner, were arrested after a 17-year-old boy died and two others were hospitalised hours after injecting themselves with an illegal drug in Balapur. The three, including two minors, crushed and injected Tapentadol Hydrochloride tablets, leading to severe medical complications. Tapentadol Hydrochloride is classified a narcotic painkiller classified under Schedule H1. Sayeed Sahil, 21, and Siroomani Jagannathan Praveen, 54, the owner of Srinivas Medical Store in Shamshabad, were arrested after the Telangana Anti-Narcotics Bureau (TGANB) flagged a social media video from a relative of the deceased. The incident was reported on the night of April 17 at a residence in Shaheen Nagar, where the three victims administered the drug mixed with saline water using syringes. They returned home after feeling dizzy. The next day, one of them, a first-year Intermediate student, was admitted to hospital in critical condition, and later shifted to Osmania General Hospital, where he succumbed on the evening of April 19. The other two, aged 17 and 22, remain hospitalised in a semi-conscious state in different private hospitals in the city and have admitted to using the tablets for the last one year. A joint team from Balapur police and TGANB traced the source of the drugs to Sahil, a resident of Shaheen Nagar, who confessed to being addicted to Tapentadol for the past year. Investigation revealed that Sahil purchased the tablets illegally (without prescription) from Srinivas Medical Store in Shamshabad, owned by Praveen. He bought the tablets for ₹45 each, and resold them for ₹150, targeting those already hooked on the drug. On his confession, police apprehended Praveen and seized the stock from his shop. The seized drugs, matched by batch number with those found at the site of the incident, were supported by CCTV footage and records of online transactions between the two. TGANB clarified that tapentadol, though not yet included under the NDPS Act, has been under national-level control in India since 2021 due to its high abuse potential. It is a centrally acting opioid analgesic that causes dependency and is strictly regulated under Schedule H1 of the Drugs and Cosmetics Rules. Police revealed that the victims were introduced to the drug by other local youth, including Mohd Ayan, 20, a student, Junaid Khan, 25, an electrician and a 16-year-old student. A case has been booked by the Balapur police and investigation is underway. Authorities have issued a strong appeal to parents, urging them to monitor their children's behaviour closely and seek help from the TGANB if signs of substance abuse emerge. Schools and colleges have also been asked to intensify awareness campaigns. Medical store owners have been strictly warned against dispensing prescription drugs without valid documentation. Officials emphasised that the sale or supply of such substances without a prescription is not only illegal but life-threatening, and violators will face serious legal consequences.
