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Mint
04-06-2025
- 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.
Mint
13-05-2025
- Business
- Mint
India tightens export rules for medicines to check wide misuse as narcotics in overseas markets
New Delhi: The Centre has tightened the rules for exports to check the wide abuse of medicines manufactured in India, three officials aware of the matter said. The guidelines are applicable to unapproved and approved new drugs for exports purpose only and manufacturers have to comply with the legal procedures, two officials aware of the matter said. Also Read | India to boost production of combat medicines With some of these drugs being used in overseas markets as narcotics, the Central Drugs Standard Control Organization (CDSCO) has introduced a two-step verification for the manufacturer that will be checked at Indian ports. In addition, the apex drug regulator has made it mandatory for manufacturers to obtain regulatory approval from the importing country for medicines classed as narcotic drugs and psychotropic substances (NDPS). Also Read | E-pharmacies, chemists at odds as govt mulls a stop to home delivery of drugs The development comes against the backdrop of unapproved Indian-made drugs being exported to countries in Africa and being rerouted to other destinations. Under the new rules, a manufacturer has to first obtain a no-objection certificate (NOC) from the Central Licensing Authority. Once approved, the consignment and all related documents will be verified at the port before shipment. Also Read | You may soon get to buy non-prescription drugs at a friendly neighbourhood store Earlier, there was no detailed verification of the manufacturer at Indian ports. The manufacturers will have to submit the details of quality of products, manufacturer's name, name of the exporting country and details of the buyer. These regulations have been made under the relevant provisions of the Drugs and Cosmetics Act, 1940 and Drug Rule, 1945. A guidance document for manufacturers seen by Mint has been issued by CDSCO. In case of unapproved FDC (fixed dose combination), unapproved NDPS and banned drugs in India, the manufacturer is required to mandatorily get the approval of the importing country's regulator. 'This entire exercise will ensure that only approved consignment will be shipped from India to the destination country. This is one way to have greater vigilance for exports of unapproved and approved new drugs from India," said one of the officials cited above. Step two involves the procedure for release of consignment at the Indian port office. 'New guidelines have been issued and these requirements were not in place and divided in two steps. The first thing is online documentation to get the NOC and the second step is physical verification at the ports. This will have uniformity and create the system of traceability all throughout the process," said the second official. As per the department of pharmaceuticals, the Indian pharmaceutical industry is worth approximately $50 billion with over $25 billion of the value coming from exports. About 20% of the global exports in generic drugs are met by India. The country has 10,000 pharmaceutical companies, out of which 2,000 are MSME drug firms. Queries sent to the health ministry spokesperson remained unanswered.
