Latest news with #DrugsRule
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.
Hindustan Times
05-05-2025
- Health
- Hindustan Times
Non-prescription drugs to be sold at neighbourhood grocery stores soon: Report
People would not have to take a trip to a medical store anymore to get non-prescription medicines such as cough syrups, pain relievers and anti-fungal cream as these drugs may soon be available at neighbourhood grocery stores, reported Mint. In a move that aims to make non-prescription drugs more accessible for people, the Drugs Technical Advisory Board (DTAB) decided in April that such drugs can be sold at grocery stores, the Mint report said citing three people familiar with the matter. However, no official notification has been issued yet. There are several drugs that can be bought in India without a signed prescription from a doctor, such as painkillers, cough syrups, anti-allergics, laxatives and anti-fungal products. These are also called over-the-counter (OTC) drugs. While the retail store owners won't need to hire a pharmacist for the sale of these drugs, they will have to obtain a licence, said the report. According to one of three sources, the government has been working on making this happen for quite some time now and a final decision is not far away. 'The government is finalizing the list of OTC drugs and products which can be sold at retail shops. The government has been working on this for a long time, and a final decision is to be taken shortly," the report quoted the person as saying, who also attended the DTAB meeting. The second official familiar with the matter told Mint that the government is working on formulating new regulations that will define what these OTC drugs are. 'Right now, OTC drugs are not defined or covered under the Drugs Rule, 1945. Once these regulations are in place, the public will be aware of what OTC drugs are, and what types of drugs can be purchased without a prescription…The move is aimed at ensuring accessibility and availability of OTC drugs to the people even in the interiors of the villages and remote areas," the official said. While the move may prove beneficial for people for cutting down their trip to a medical store to get a non-prescription drug, it puts medical stores and chemists at a risk of loss of sales. The All India Organization of Chemists and Druggists (AIOCD) is not in favour of the move and has been opposing it. Expressing concern over how the move will unfold and affect chemists, AIOCD's general secretary Rajiv Singhal said, 'Where will we go? This will put the growth of pharmacists at risk.' He said that letting retail stores sell OTC drugs can lead to misuse and had urged the government to consult and be transparent with chemists before making any decision. "We are going to submit our representation to the government to seek a transparent and balanced approach in finalizing the sale of OTC drugs at retail level and involve stakeholders like the Indian Medical Association, doctors and Indian Pharmaceutical Association (IPA) before finalizing the change," he said. According to the third person familiar with the matter, a list of OTC drugs has already been prepared by the sub-committee and is on the way of getting a final nod after the government re-issues a 'draft notification on OTC drugs regulation' and takes stakeholders' comments.
Mint
05-05-2025
- Health
- Mint
You may get to buy non-prescription drugs at a friendly neighbourhood store
Cough lozenges, pain relievers and anti-fungal creams may soon be available at a neighbourhood grocery store near you, in a move that promises easy access to common medicines but raises concerns of potential misuse. The Drugs Technical Advisory Board (DTAB) decided last month that several medicines that do not need a prescription may be sold at retail outlets, three people aware of the matter said. These include analgesics, anti-allergics, antihistamines, cough syrups, laxatives, antifungal products, and certain asthma drugs. Though retail stores won't need a pharmacist like regular chemists, they will need to secure a licence for selling these medicines, also called over-the-counter (OTC) drugs. 'The government is finalizing the list of OTC drugs and products which can be sold at retail shops. The government has been working on this for a long time, and a final decision is to be taken shortly," said one of the three people cited above, who attended the DTAB meeting. The move spells relief for consumers who can pick up these medicines from just about anywhere, but also casts a pall of gloom over tens of thousands of chemists staring at loss of sales. Queries emailed to the Union health ministry remained unanswered. New regulations will define OTC drugs and formulate a separate schedule for them, the second official said. "Right now, OTC drugs are not defined or covered under the Drugs Rule, 1945. Once these regulations are in place, the public will be aware of what OTC drugs are, and what types of drugs can be purchased without a prescription, the official said. 'The move is aimed at ensuring accessibility and availability of OTC drugs to the people even in the interiors of the villages and remote areas," the official added. Also read | Healthify shifts gears to incorporate weight-loss drugs, cash in on anti-obesity boom The All India Organization of Chemists and Druggists (AIOCD), which represents 1.24 million members and the Indian Pharmaceutical Association representing 13,000 members, have protested against the plan ever since the government floated the idea of selling OTC drugs at retail shops years ago. 'Where will we go? This will put the growth of pharmacists at risk," said Rajiv Singhal, general secretary of AIOCD. "We are going to submit our representation to the government to seek a transparent and balanced approach in finalizing the sale of OTC drugs at retail level and involve stakeholders like the Indian Medical Association, doctors and Indian Pharmaceutical Association (IPA) before finalizing the change," Singhal said, adding OTC drugs at retail stores may also lead to misuse. The government must share the list of retail OTC drugs with chemists so they can provide feedback on the pros and cons of the decision, he added. 'The sub-committee has prepared a list of OTC drug items. The government will now re-issue a draft notification on OTC drugs regulation, take stakeholders' comments before giving the final nod," the third official added. Read this | Demand for weight loss drugs is growing. Can wellness companies keep up? In 2022, the Centre had issued a draft notification permitting the sale of 16 specific OTC drugs without a prescription by retailers with a valid licence, a move that chemists' bodies have opposed since then. In 2024 , the DTAB formed a sub-committee to develop a detailed mechanism for the drugs to be considered as OTC. DTAB agreed with the sub-committee's recommendations. 'Legal provisions to be enabled under Drugs Rules, 1945 along with manner of submitting application, prescribe the licensing requirements for the sale of OTC drugs which does not require the supervision of registered pharmacist, requirements for considering a drug as an OTC, labelling requirements, etc. and incorporation of a separate schedule," the meeting's minutes showed. Experts agreed on the need for OTC drug regulations. "These drugs are generally regarded as safe within their therapeutic dosage and therefore, 'responsible people' can use them," said Dr. Y.K. Gupta, who has headed the All India Institute of Medical Sciences' pharmacology department. However, he noted that many Indians may not be educated enough to choose these medicines wisely, and hence, there is a possibility of abuse or overuse. The decision will make OTC drugs widely available to the public, Gupta said, while pointing to the easy availability of even prescription drugs and antibiotics over the counter. "We have to have a balanced approach in terms of accessibility, availability and avoiding inconvenience," said Gupta, who is also the national scientific coordinator of India's pharmacovigilance programme to ensure drug safety. And this | Govt to add 100 key drugs to widen availability of affordable medicines at Janaushadhi kendras In several countries, a large number of drugs are available off the shelf without a prescription. According to AIOCD's Singhal, India sees annual pharmaceutical sales of ₹ 1.98-2.3 trillion, out of which OTC accounts for ₹ 30,000-40,000 crore. Dr. Suranjeet Chatterjee, senior consultant of internal medicine at Apollo Hospital said the only benefit is easy availability of OTC drugs, with some downside. 'There could be a misuse of OTC drugs, and people can take the drug on their own since it does not require a doctor's prescription. The pharmacist is a qualified person, and he knows what to give to the customer. I am not totally against this decision, but at this stage, I am a bit sceptical about it. Even in the US, paracetamol and anti-allergic tablets are available at the grocery shop, but we cannot compare India with US, because people are less educated here and have no knowledge of the medicines," Dr. Chatterjee said, calling for a structured regulation. The list as submitted by the sub-committee may be considered initially, which will be dynamic and updated from time to time, the DTAB minutes said. The board also recommended a comprehensive revisit of the draft notification, for which international guidelines may also be considered and directed the sub-committee to submit a report on it. And read | IPC raises concern over five lifesaving drugs for causing adverse reaction Some of the OTC drugs that could go on retail shelves include Chlorohexidine Gluconate 0.2% (for the treatment of gingivitis), paracetamol tabs 500 mg (antipyretic), sodium chloride nasal spray, ketoconazole shampoo (anti-dandruff), lactulose solution (laxative), calamine lotion (anti-septic), xylometazoline hydrochloride (nasal decongestant) and bisacodyl tablets 5mg (laxative).
