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The Hindu
18-06-2025
- Health
- The Hindu
Conference on pharmaceutical quality assurance through good manufacturing practices held in Mysuru
A national conference on 'Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices' was conducted by the JSS Academy of Higher Education and Research in Mysuru on Wednesday. It was held in association with the Indian Pharmaceutical Association, Mysuru branch, along with other organisations, and included a session on Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS). A release said that the initiative aimed to ensure consistent production and control of medicinal products to meet the highest quality standards. The primary objective of the conference was to promote the understanding and implementation of Good Manufacturing Practice (GMP) principles among pharmaceutical manufacturers, emphasising the importance of adherence to GMP standards for ensuring the safety, efficacy, and quality of medicinal products, the release added. The conference also aimed to provide guidance on incorporating GMP requirements into national medicine laws and regulations, while facilitating the exchange of best practices in GMP implementation. The conference was inaugurated by Dr. Khalid Ahmed Khan, Deputy Drug Controller and president of the Indian Pharmaceutical Association (IPA), Karnataka State branch. Dr. H. Basavana Gowdappa, the vice chancellor of JSS Academy of Higher Education & Research, Mysuru, urged the industry to view GMP not merely as a regulatory requirement, but as a core responsibility. Dr. Amaresh Tumbagi, former Drug Controller of the Karnataka government, highlighted various inspections conducted under Schedule M and discussed how regulatory bodies have evolved with the revised version. Dr. Pramod Kumar T.M., Principal, JSS College of Pharmacy, Mysuru, provided insights into industry and government regulations related to GMP. Around 100 delegates from different industries and academics were present apart from the members of IPA Mysuru branch. Dharmendra Kumar Yadav, Under Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, Yashwant Shinde, Manager, Small Industries Development Bank of India (SIDBI), and Dr. R.S. Savitha, Secretary, IPA Mysuru, were among those present.
News18
10-06-2025
- Health
- News18
‘Revamp E-Prescription Rules': Chemist Lobby Asks For Mandatory ‘Dispensed' Stamp To Curb Re-Use
Last Updated: The letter flagged that a patient could use the same prescription as a soft copy or a printout of the soft copy at different pharmacies to repeatedly purchase the same medicines The Indian Pharmaceutical Association (IPA) has written to the apex drug regulator demanding 'urgent modifications" to the current rules governing e-prescribing and e-prescriptions to 'prevent inconvenience, misuse and contravention of laws". In a detailed letter, seen by News18, the lobby of pharmacists has pointed out loopholes in the country's telemedicine practice guidelines and the health ministry's e-Sanjeevani guidelines. The letter sent to the Drugs Controller General of India (DCGI) on June 9 highlights concerns regarding the current guidelines, which allow prescriptions to be sent directly to patients following teleconsultations. 'The issue is that the same prescription, as a soft copy or a printout of the soft copy, could be shown or used by the patient at different pharmacies to repeatedly purchase the same medicines listed on it. This can lead to repeat dispensing and misuse and is detrimental to public health," the letter said. It added that current guidelines lack 'any means of checking, confirming, or stopping this". The IPA has called for the Drugs & Cosmetics Act and Rules to be revised so that 'the pharmacist must put a 'Dispensed' stamp on an original printout of the prescription," and that this provision be expanded to cover e-prescriptions as well. Adapt the global ecosystem According to the letter, which is also sent to the Directorate General of Health Services (DGHS) and the Pharmacy Council of India (PCI), e-prescribing systems are globally proven to enhance efficiency and safety, but India must tailor its approach to local conditions. The letter cites the example of Australia, stating that the country also introduced electronic prescribing in May 2020 after they built a robust system that allows doctors to electronically prescribe medications to patients in the form of an encrypted QR code or text message. The catch here is that upon visiting the pharmacy of his choice, the patient shows the QR Code or text message, and the pharmacy scans it. Following this, the prescription is generated. 'The safety factor here is that the patient cannot repeatedly use the same prescription," the letter said. What should India do? 'We request you to please understand the situation: Very often, such e-prescriptions will be from doctors who are not from the patient's city or state. The pharmacist to whom the patient brings the prescription is in a dilemma as to whether the prescription is authentic or not." To eliminate such ambiguity, the IPA in the letter suggests a systemic overhaul. 'The law must mandate that the doctor either electronically send the prescription directly to the pharmacy or provide it in an encrypted mode to the patient, which only a pharmacy can decode, and not the patient." Highlighting the role of the Ayushman Bharat Digital Mission (ABDM), one of the flagship schemes of the Modi government, the letter said, 'The ABDM is already in the process of providing unique identities to pharmacies and pharmacists; integrating the receipt and access of e-prescriptions should be a natural extension of this initiative." Experts hold a different view While the IPA has called for a system that withholds direct prescription access from consumers, experts News18 spoke to hold a different view. 'The intention of IPA is in the right direction, but it won't be correct to take away the rights of patients. This will shift all power into the hands of pharmacists and pharmacies," said a former official from the National Medical Council (NMC) who was part of the panel framing the telemedicine guidelines. Echoing a similar observation, another official, an industry veteran running a successful e-pharmacy firm, told News18 that the suggestion 'restricts choice for a consumer and structurally will create a doctor-pharmacy nexus, taking away the freedom of choice from a consumer". 'Also, if the pharmacy to which the prescription goes does not have all the medicines in the prescription, which is very normal – then the consumer has no method of access," he said, adding that the pharmacies have no incentive to provide service and affordability to the patients since the consumer is helpless and dependent on them. Location : New Delhi, India, India First Published: June 10, 2025, 09:36 IST News india 'Revamp E-Prescription Rules': Chemist Lobby Asks For Mandatory 'Dispensed' Stamp To Curb Re-Use
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).
