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Booster dose: India inches closer to regulatory framework for OTC drugs
Sources in the Drugs Technical Advisory Board (DTAB) told Business Standard that on Thursday they had okayed the recommendations made by the eight-member OTC sub-committee in its report. 'Now, this would be taken up by the health ministry, and once its approval comes through, the framework and guidelines can be formalised. It is a move in the right direction as India lacks a clear and formal category of OTC and a comprehensive list of OTC drugs,' said one of the sources. He further elaborated that the OTC sub-committee had studied 126 drugs and then finalised around 30 of them that fit the OTC category after research and stakeholder consultation.
'This would make sure that for day-to-day ailments, patients could buy necessary medications. The duration for which these medicines can be used has been kept low to avoid misuse. We have suggested that instead of a five-day cap on dosage distribution, it could be kept a bit flexible for certain categories. For example, if you have a sprain, you may use a topical pain-management ointment for more than five days,' the source explained. He felt that it would raise demand for OTC medicines.
Dr Anupam Prakash, the OTC sub-committee chairman, said that the report is an attempt to bring in regulations for these drugs and create a mechanism for determining which medications would qualify as OTC drugs, incorporating suggestions from clinicians and other stakeholders. He said that around 27 drugs have been chosen to be dispensed as OTC.
Last year, the Central Drugs Standard Control Organisation (CDSCO) had formed the sub-committee to draw up a framework for OTC drugs, and also create a mechanism to determine which medicines can qualify as OTC.
The drugs of common use for day-to-day ailments will be available as OTC, and these medicines would have a good safety margin so as not to unduly compromise the health of the common man consuming the same.
'This includes medications that are part of the National List of Essential Medicines (NLEM) and are approved for distribution by the CDSCO,' Prakash added. Calling it the first attempt at bringing a separate rule for regularising OTC drugs since Independence, Prakash said that the sub-committee has recommended a proposal to accept applications for adding other drugs in the OTC list in the future.
'We have proposed that a protocol be enshrined for revision in the list if any stakeholder wants to apply, fulfilling certain guidelines,' he added.
Experts have cautioned against self-medication across categories, and, therefore, having a clear list of OTC medications will help reduce misuse.
Dr Tushar Tayal, consultant, internal medicine, at CK Birla Hospital, Gurugram, said that self-medication with drugs such as antibiotics, painkillers, and sedatives, commonly bought from chemists without a prescription, can lead to significant health risks and side effects.
'Antibiotics like amoxicillin, ciprofloxacin, and azithromycin are frequently used without medical guidance. Improper or incomplete use of antibiotics can lead to antibiotic resistance, making future infections harder to treat and spreading resistant bacteria in the community,' he added.
Tayal said painkillers, especially Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen, diclofenac, and naproxen are also commonly misused, which can irritate the stomach lining, leading to ulcers and bleeding, and in some cases cause kidney damage or raise the risk of heart attack and stroke.
Some analysts said that with a clear list of OTC drugs and an attempt to regulate this space, there can be some impact on volumes.
Nirali Shah, analyst with Ashika group, said that a clampdown on OTC drug sales could dent Indian Pharma Market (IPM) volume growth, especially in the acute therapy segment where self-medication is rampant in analgesics, antipyretics, and common cold medicines. 'IPM value may hold up in the short term due to price stickiness and a higher share of chronic therapies, but overall market growth could soften if consumer access is restricted or redirected,' she said.
Most analysts don't see much of an impact on volumes as such.
Sheetal Sapale, vice-president, commercial, Pharmarack, said that it is difficult to draw up the exact size of OTC medicines as there is no clear list. Typically, drugs like analgesics, antiseptics, contraceptives, some vitamins, laxatives, cough syrups, etc. are dispensed as OTC. Sapale does not think volumes would be impacted once OTC regulations come into place.
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NDTV
10 hours ago
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The Hindu
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As the country was born anew, independent, soon to be a republic, the new government exhorted people to be proud of the Independence Struggle that facilitated the transfer of power, but on the health indices front, pride would not have been an appropriate emotion. As Sanjay P. Zodpey, and Preeti H. Negandhi summarised in a paper in the Indian Journal of Public Health, according to the '1951 Census, India's population was 36.1 crores, at independence... The overall life expectancy was 32 years. The infant mortality rate (IMR) was 145.6/1000 live births. Maternal mortality ratio (MMR) in the 1940s was 2000/100,000 live births, which apparently came down to 1000 in the 1950s. There were only 50,000 doctors across the country. The number of primary health-care centers in the country was only 725.' Fatal infections At the time of Independence, the litany of health challenges would fill several volumes and spill over: the country was battling widespread prevalence of infectious diseases that had a fatal effect — including malaria, tuberculosis, smallpox, and cholera. As already discussed, maternal and child mortality was also very high. The focus, naturally, was on addressing these communicable diseases. India clearly had a lot of work to do, to improve health services, even as it set about the task of nation building. In retrospect, much of the progress that India has seen today was thanks to the foundations laid during this intense period, though policies kept changing over the years, as they indeed do, and must. Retrospect is a wonderful teacher, and it is clear today, where the investments in the health sector should have been in, 80 years ago. Would that have fast-tracked improvements, reduced mortality and morbidity, and improved quality of life? No doubt. Incremental measures, not only in the health sector, implemented over the years, have pulled the nation to a situation that has of course dragged it to a modern century. The first such measure to make a difference was the Bhore Committee report, in 1946. In fact, this visionary document would go on to build the scaffolding on which Indian health care would continue to go on, and retain, even seven decades down the line. The Bhore Committee laid the foundation for a state-led healthcare model, emphasising universal access and preventive care. As a consequence, the basic building blocks of the Indian health care system — the Primary Health Centres (PHCs) and sub-centres were set up. This network has remained, and grown, over the years, taking access to more people at the very lowest rung. As mentioned, the government was busy fighting infectious diseases, and key moments, also to be replicated later, included the launch of interventions in a programme mode at the national level. The National Malaria Control Programme was instituted in 1953, followed by the National Tuberculosis Programme and the Expanded Programme on Immunisation. Significant milestones It was the focus on immunisation that enabled the country to mark two significant milestones that also ensured fewer deaths and a better quality of life for its citizens. The first significant milestone was the eradication of smallpox in 1980, along with the rest of the world. Smallpox was a highly contagious and disfiguring disease, and with a high fatality rate, with about 30% of those infected dying. The second came at least 25 years later in 2014 with the WHO certifying that the country had eliminated polio. Interestingly, these campaigns were executed as mass public outreach programmes, with the effort of several players including the state and non-state actors involved in massive immunisation work, besides extensive awareness and communication activities explaining the importance of such vaccination. Advances have since been made in reducing maternal and infant mortality with Kerala leading the country in achieving targets in the these parameters, and Tamil Nadu following in its footsteps. Certain Northeast States have enviable single-digit numbers for IMR. Overall, infant mortality fell from around 161 per 1,000 live births (1947) to about 26 per 1,000; maternal mortality dropped from over 2,000 per lakh (100,000) live births to around 103 in 2024. However, even today, with the advancements, large regional variations contribute to increasing the national mean, in both infant and maternal mortality gains. Intra-country and intra-State variations are still high in many parts of India, both with IMR and MMR. The roll-out of the New Economic Plan in the 1990s was to leave a lasting impact on health care services in the country, and change it, fundamentally. Pegged on the concepts of liberalisation, privatisation, and globalisation, the NEP made the private sector a significant player in the health care scenario, hoping to level the playing field, and increase access, efficiency and quality of services. While these ramped up service delivery, contributed massively to India's position as a destination for affordable, quality medical tourism, they indeed did queer the pitch — issues of increased out-of-pocket expenditure, and access for only those who could afford it cropped up. These continue, in some ways, till date. This period also gave impetus to the pharmaceutical industry to grow into one of the largest in the world, supplying generics globally. Simultaneously, a significant factor was the growth of medical colleges across the country. This helped increase the number of trained medical professionals available in India to serve the people. However, a great urban-rural divide still exists, with urban centres faring better than their rural counterparts. ASHA's entry But it was later, in 2005, with the launch of the National Rural Health Mission, that a true attempt was made to improve health care delivery in rural areas. Among its successes we must count the ASHA (Accredited Social Health Activist) — a cadre of female health care workers working with the community was created to take health awareness and health services directly to the doorsteps of the people in the villages. The National Health Mission, later, zeroed in on a clear mandate to improve access to healthcare even in urban areas. With an epidemiological shift occurring in the country, over the years, India has come to accumulate a huge burden of non communicable diseases — diabetes, hypertension, cardiovascular diseases — as a result of changing lifestyles and eating habits, and a strong genetic component. The government has also shifted track to addressing these issues through national programmes launched across the country, and in the meantime, with the threat of infectious disease outbreaks still remain alive. In fact, the threat from tuberculosis, which was among the first few national health programme started, is still virulent, with further assaults from resistant strains derailing progress on the front. Investments in health care research, in the public and private sectors, have ensured that the lag on that front is also being addressed. Research into newer molecules, vaccine platforms, and rare diseases will provide the country an edge in the future, the challenge would be to ensure that these state-of-the-art therapeutics and diagnostics are available to, and accessible by all. At this juncture, India is poised on the edge of a demographic transition. While fully geared to take advantage of the youthful population, it also needs to provide for a future that will be largely grey. As it nears the final stages of reaping its demographic dividend, the nation will also have to plan to take care of the health requirements of an ageing population. The task ahead is by no means simple, there are no magic bullets, but India has learnt that ensuring health for all, consistent delivery of a standard of care to all segments of the population, irrespective of their ability to pay, is the only steady way ahead.
