Tag Archives: Over The Counter

OTC Drugs in India: ‘Where Art Thou?’

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It is now a widely accepted fact that responsible self-medication plays an important role in health care, facilitating greater access to medicines and reducing overall health care cost. With continued improvement in people’s education, general knowledge and socioeconomic conditions, self-medication has been successfully integrated into many health care systems, throughout the world.This was emphasized in the paper “The benefits and risks of self-medication,” published by the World Health Organization (WHO) based on a presentation of the WHO Coordinator, Quality Assurance and Safety: Medicines, way back in March 2000.

Which is why, calibrated deregulation of prescription drugs for ‘Over the Counter (OTC)’ sale, are helping many countries to expand drug access in a cost-effective manner, facilitating overall health care, through responsible self-medication.

In this article, I shall try to explore the OTC drug issue in India, against the backdrop of the veracity of dangerous and virtually uncontrolled self-medication in the country. It will be interesting to recap where India stands in this area, despite the enactment of so many relevant laws and rules to eliminate this menace. In tandem, it will be worthwhile to fathom why is India still keeping away from promoting responsible self-medication through OTC drugs? Even when this is widely considered as one of the effective ways to improve access to drugs for specified common ailments at a reduced treatment cost for patients.

OTC Drug in India: ‘Where Art Thou?’ – becomes a relevant question in this context. Let me pick up the thread of this discussion from the general belief among a large number of domain experts that OTC drugs facilitate responsible self-medication.

OTC drugs facilitate responsible self-medication:

For greater clarity in this area, it will be worthwhile to first recapitulate the definition of self-medication. The W.H.O has defined itas, ‘the practice whereby, individuals treat their ailments and conditions with medicines which are approved and available without prescription, and which are safe and effective when used as directed.’

Whereas, self-medication with prescription drugs is not only an irresponsible act, it can often be dangerous to health for the users. On the other hand, OTC drugs facilitate responsible self-medication, as the drug regulators of respective countries have included under this category, with clear guidelines, only those medicines, which:

  • Are of proven safety, efficacy and quality standard.
  • And indicated only for conditions that are self-recognizable, and some common chronic or recurrent disorders.
  • Should be specifically designed for the purpose, will require appropriate dose and dosage forms and necessarily supported by information, which describes: how to take or use the medicines; effects and possible side-effects; how the effects of the medicine should be monitored; possible interactions; precautions and warnings; duration of use; and when to seek professional advice.

Since, OTC drugs facilitate responsible self-medication, it will be interesting to know how the constituents of Big Pharma, such as Pfizer, view the social impact of legally recognized OTC drugs.

Social impact of self-medication with OTC drugs:

Like many other large global pharma players, Pfizer also believes: “OTC medicines provide easier access to treatment options for common conditions, offering not only convenience, but also timely treatment and relief for sudden symptoms or minor ailments.” The company also acknowledges, OTC medicines, as classified so by the drug regulators of a country, “provide consumers safe and effective treatments for commonly occurring conditions, saving them time and money that might otherwise be invested in other, more expensive health services.”

To substantiate the point, Pfizer communique referred to the U.S. study, which by analyzing the seven most common acute and chronic, self-treatable conditions found that 92 percent of those who use OTC medicines in a given year are likely to seek more expensive treatment elsewhere, if OTCs were not available.

The above may be construed as a generally accepted view of both, the drug regulators and a large number of drug companies, globally. Thus, it won’t be a bad idea to quickly have a glance at the process followed by the drug regulators of the major countries, such as US-FDA, for OTC classification of medicines.

US-FDA classification of OTC medicines:

In most countries of the world, as many of us would know, those who are permitted to sell drugs under a license, can sell two types of drugs, namely: prescription drugs and nonprescription drugs. OTC medicines, obviously, fall under the nonprescription category.

Briefly speaking, US-FDA defines OTC drugs as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.”The Agency reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example, analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of ‘recipe book’ covering acceptable ingredients, doses, formulations and labeling.

Many of these monographs are found in section 300 of the Code of Federal Regulations. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness and labeling of all marketing OTC active ingredients. While this is the scenario in the United States and a large number of other countries, let’s have also a glimpse of this aspect in India.

‘OTC drugs’ in India:

As on date, legally approved as OTC drugs along with the guidelines, for responsible self-medication during pre-defined common illnesses, doesn’t exist in India. Accordingly, neither drugs & Cosmetics Act, 1940 nor the Drugs & Cosmetics Rules, find any mention of OTC drugs, as yet. While even responsible self-medication is not legally allowed or encouraged in the country, ‘self-medication’ of all kinds and of all nature are rampant in India, possibly due to gross operational inefficiency on the ground.

Several research papers vindicate this point. One such study that was done with 500 participants, reported 93.8 percent self-medication with no gender difference. The most common reasons for self-medication were found to be – 45.84 percent for fever, 18.34 percent for pain, and 10.87 percent of headache, among others. While the common medications used were listed as nonsteroidal anti-inflammatory drugs 49.4 percent, followed by antibiotics 11.6 percent, besides other drugs.

Among those participants who took self-medication were of the opinion that self-medication resulted in quick cure of illness – 50.75 percent, saved their time – 17.46 percent, and gave them a sense of independence – 17.06 percent. The most common source of information was found to be a local chemist/pharmacy – 39 percent.

Raising a flag of concern that indiscriminate self-medication is dangerous for the population, the study suggested that public health policies need to find a way of reducing unnecessary burden on healthcare services by decreasing the visits for minor ailments. One such way is a well-defined OTC category of medicines, as are being created in many countries, including the United States. However, it appears, the Indian drug regulators are still apprehensive about giving a formal recognition of OTC drugs in the country, to prevent self-medication that is, unfortunately, rampant in the country, even otherwise.

Self-medication rampant, although illegal in India:

Regardless of all drugs laws and rules being in place to prevent self-medication with prescription drugs, these seem to be just on paper, the ground reality is just the opposite in India. In the absence of a clearly defined category of OTC drugs with guidelines, most medicines falling under the drug act, are prescription drugs, except a few drugs on the Schedule K of the Drugs & Cosmetics Act. Currently, non-pharmacy stores can sell a few Schedule K drugs classified as ‘household remedies’ onlyin villages with less than 1,000 populations, and where there is no licensed dealer under the Drugs and Cosmetics Act.

Primarily to prevent self-medication and also to ensure maintenance of specified storage conditions, among others, the D&C Act requires all other drugs to be sold by a retail drug license holder and sold only against the prescriptions of registered medical practitioners. Such drugs are labeled with a symbol ‘Rx’ on the left-hand corner of the pack and the symbol ‘NRx’, if drugs fall under Narcotic Drugs and Psychotropic Substance Act.

Additionally, these are also labeled with a warning – ‘To be sold on the prescription of a registered medical practitioner only.’ All retailers, pharmacy/medical store are supposed to strictly abide by this directive. But in reality, who cares? One can possibly get most prescription drugs that one wants, without a doctor’s prescription.

The same holds good for virtually unregulated advertising of some self-categorized ‘OTC drugs’, many of which fall under the prescription drug category. I re-emphasize, the terminology of OTC drugs does not exist, at all, in the D&C Act of India, not as yet.

Virtually uncontrolled advertisements of some so called ‘OTC’ drugs: 

Media reports indicate, widespread complaints received in the drug controller general of India (DCGI)’s office that vitamin tablets and capsule formulations are being marketed in the country as dietary/food supplements to circumvent the Drugs Price Control Order (DPCO).

Curiously, to resolve this issue – way back on July 24, 2012, the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, deliberated on the OTC drug issue in India. After detailed discussion, the DTAB has given its green signal to amend Schedule K of the Drugs and Cosmetics Rules in this regard.

But Food safety watchdog Food Safety and Standards Association of India (FSSAI) did act promptly on this matter. On September 24, 2016, FSSAI), reportedly, issued new guidelines clearly specifying that health supplements should not be sold as medicines and also fixed the permissible limits of various ingredients used in the products. It further said: “Every package of health supplement should carry the words health supplement as well as an advisory warning not for medicinal use prominently written.

“The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by the international food standards body namely the Codex Alimentarius Commission shall apply,” FSSAI added.

The juggernaut moves on:

The point worth noting here that all laws, rules and regulations are in place to discourage both, self-medication and surreptitious way to sell products sans medicinal values, as medicines. Despite the enacted laws and rules being reasonably robust to achieve the intended objective, inefficient implementation of the same keeps the juggernaut moving, perhaps gaining a momentum.

Is OTC Drug Category coming now or just another good intent?

The good news is: On September 18, 2017, the Drug Consultative Committee (DCC), in principle approved to amend rules on Drugs and Cosmetics Act to include a separate schedule for OTC drugs for minor illnesses like fevers, colds and certain types of allergies. However, in the meeting of February 20, 2019, the DCC constituted another subcommittee under the chairmanship of Drugs Controller, Haryana to examine the report on OTC drugs. The final decision is still awaited without any prescribed timeframe for the same.

Conclusion:

Creation of separate schedule for OTC drugs in India, is still a contentious issue for some. Nonetheless, such a long overdue amendment in the D&C Act, along with well-regulated OTC guideline as and when it comes,I reckon,will expand drug access to patients. Alongside, the drug makers must ensure that these OTC medicines are safe, effective and offering good value for money.

As the author of the above W.H.O articled emphasized: ‘High ethical standards should be applied to the provision of information, promotional practices and advertising. The content and quality of such information and its mode of communication remains a key element in educating consumers in responsible self-medication.’ Thus, in the Indian context, it will be equally essential for drug companies to make sure that OTC medicinesare always accompanied by complete and relevant information that consumers can understand without any ambiguity.

Be that as it may, I agree, even responsible self-medication is not totally risk-free – not even with OTC drugs, just as many other things that we choose to do in life. The risks associated with the use of OTC medicines may include, risks of misdiagnosis, excessive drug consumption and for a prolonged duration, precipitating drug interactions, side-effects and polypharmacy.

This discussion will remain theoretical until the D&C law and rules are appropriately amended to accommodate much awaited OTC category of medicines. Till then one can possibly ask in India: ‘OTC drugs, where art thou?’

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

An Interesting demand: No Price Control For OTC Drugs

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Since over a decade, some pharma trade organizations operating in India, have been advocating for a separate regulatory policy for ‘Over The Counter (OTC)’ drugs, which can be legally sold without any medical prescriptions. Such a new policy initiative, if taken by the Indian Government, would call for inclusion of a separate Rule and a Schedule in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

In the midst of cacophony related to Intellectual Property (IP) related priority of the industry in multiple areas, OTC drug advocacy took a back-seat, temporarily. Some recent developments indicate, it has again been taken out of the trade associations’ archive, well-dusted, rehashed and re-presented. Today’s key driver is likely to be increasingly stringent drug price control measures of the government. An emphatic demand of the pharma trade associations that OTC drugs should be kept outside drug price control measures, vindicates this point.

In this article, I shall deliberate this issue, especially on raising the same old demand – yet again, and my concerns on the demand of free-pricing for essential OTC drugs, in the Indian context.

OTC drugs – no legal status in India:

Currently, OTC drugs have no legal status in India. However, those drugs which don’t feature under ‘prescription only’ medicines are construed as ‘non-prescription’ drugs and sold over the counter at pharma retail outlets.

Neither is there any concept currently existing in India, which is similar to ‘prescription only to OTC drug switch,’ unlike many developed countries, such as UK, EU and United States. Thus, before proceeding further, let me deliberate on the important point – why is ‘prescription only drug’ to ‘OTC drug’ switch. Let me briefly dwell on this issue, quoting from a neutral source – the World Health Organization (W.H.O).

‘The basic purpose of re-designation of a drug as an OTC product is commercial’:  

The Essential Medicines and Health Products Information Portal – A World Health Organization resource illustrates the point as: After a new drug has been in use as a prescription-only medicine (POM) for an agreed period after licensing – usually five years – and has proved to be safe and effective during that time, regulatory authorities are prepared to consider submissions for re-designating the product where appropriate so that it becomes available for non-prescription “over the counter” (OTC) use.

The article further states: “The basic purpose of re-designation of a drug as an OTC product is frankly commercial; the manufacturer requests the change in the hope that, without the need for a prescription, the sale of the drug will increase. However, the change also has a secondary effect in that the drug will no longer – at least in its OTC form – be primarily funded by a national health system or insurance fund; if he had obtained the drug by private purchase, the patient will pay for it in cash, and this will therefore result in cost savings to the health system.”

Benefits of OTC drugs to patients in the western world:

An article titled, ‘When Rx-to-OTC Switch Medications Become Generic’,published in the U.S. Pharmacist on June 19, 2008, highlights the key benefits of generic OTC drugs to patients, mostly in the western world as follows:

  • Prices for generic OTC versions are lower than those for the branded products.
  • The savings vary from product to product, but they can be as little as 11 percent (some omeprazole generics) to over 75 percent (some loratadine generics).
  • The cost savings can be critical in making self-care decisions.
  • For patients with a chronic, self-treatable medical condition, the addition of a new generic OTC with that indication expands the range of therapeutic options.

Endorsing the point that ‘OTC drug’ cost significantly less than the ‘prescription only drug’ other studies also point out the following:

  • Less lost work time and costs saved by not needing to visit a doctor are important considerations.
  • Growing sophistication and self-reliance among consumers, with increasing interest in and knowledge about appropriate self-medication.
  • Older adults in particular tend to experience increased minor medical problems, such as arthritis, sleeping difficulties, muscle aches and pains, headaches and colds. Thus, as the population ages the demand for non-prescription drugs escalates.

To illustrate the point of greater choice to patients, the article cited an example of allergic rhinitis patients. It pointed out that at one time, such patients had little to choose from other than older (first-generation) antihistamines. When loratadine (Claritin) and cetirizine (Zyrtec) switched from ‘prescription only’ to generic OTC drugs, price-conscious patients got the expanded option to choose from them based on their unique advantages and lower prices.

Benefits of OTC drugs for drug manufacturers:

Several studies concluded the following when it comes to benefits of OTC drugs for the drug manufacturers:

  • When an innovative drug loses patent protection, expanding into OTC segment with the same product can help a lot in the product life-cycle management.
  • Additional revenue with OTC drugs help increasing the concerned company’s both top and the bottom-lines.

Does ‘only prescription drug’ to ‘OTC drug’ switch help Indian patients?

The key benefit that patients derive out of any switch from ‘prescription only drug’ to ‘OTC drug’ switch, has been shown as cheaper price of generic OTC drugs. In India that question doesn’t arise, because an ‘OTC generic drug’ can’t possibly be cheaper than ‘prescription only generic drugs’ of the same molecule. On the contrary, if the demand for putting generic drug outside price control is implemented, it would likely to make ‘OTC generic essential drugs’ more expensive- increasing already high out of pocket (OOP) drug expenses, without benefitting patients, tangibly.

How would OTC drugs help patients in India?

According to reports, pharma trade associations claim that ‘OTC drugs will help Indian patients. Some of the reasons given by them are as follows:

  • Responsible self-medication: Empowers patients to make responsible and wise choices and self-manage their health outcomes.
  • Improves access to medicines: ‘Access to medicines’ in India has long ignored the critical role of the viability of OTC medicine, which could play a critical role in improving access to medicines in India, especially in the remote areas.
  • Help both health system and consumers saving money: OTC medicines save health systems valuable resources and can save consumers time and money.

While the basic purpose of re-designation of a drug as an OTC product is commercial – as articulated in the above article of the W.H.O, it is interesting to note, how it is being camouflaged in India by a trade association. The association demands a brand new OTC drug regulatory policy without any price control, and at the same time says, ‘the patient is at the core of all our activities.’ I wonder how – by increasing the burden of OOP drug expenses for patients? Let me try to fathom it raising some basic questions, in context.

Some basic questions:

While trying to understand each of the above three ‘patient benefits with OTC drugs’, as highlighted by the pharma trade association, I would strive to ferret out the basic questions in this regard, as follows:

  • Responsible self-medication:Fine. But again, won’t it make totally price and promotion deregulated OTC drugs more expensive than the existing equivalents of essential drugs – significantly increasing OOP for patients?
  • Improves access to medicines: Improving drug access comes with increasing affordability, especially in India. With OTC drugs being presumably higher priced than other generic equivalents, how would it improve access? Just to illustrate this point, one pharma trade association has cited examples of the following drugs, for inclusion in the OTC category:

“Paracetamol, Aspirin, Antacids, Topical preparations of certain NSAIDs (Ibuprofen, Diclofenac), Cetirizine, Albendazole, Mebendazole, Povidone‐Iodine preparations, Ranitidine, Ibuprofen (200mg), Normal saline nasal drops, Xymetazoline nasal drops, etc. In addition to all Drugs which are currently under Schedule K.”

If the prices of OTC versions of the above drugs are kept more than the prevailing ceiling prices for essential, would it benefit the patients and improve access to these drugs for them?

  • Help both health system and consumers saving money: Doesn’t the same reason hold good for this one too?

One may also justifiably ask, why am I presuming that OTC drug prices will be more than their non-OTC equivalents? My counter question will be, why is the demand for total regulation of price for OTC drugs? In any case, if a non-schedule drug is included in the OTC category, the question of any price control doesn’t arise in any way.

The current status in India:

Unrestricted sale of ‘prescription only drugs’, including all antibiotics and psychotropic drugs, is rampant in India, causing great harm to the Indian population. In tandem with strict enforcement of the drug dispensing rules in India, a separate patient-friendly category of OTC drugs would certainly help significantly. As a concept, there is no question to it. But the devil is in the detail of demand for the same.

Accordingly, in November 2016, the Drugs Consultative Committee (DCC) formed a sub-committee for charting a regulatory pathway for sale of OTC drugs in India, specifying punitive measures for any violation of the same. As I indicated above, currently, any drug that doesn’t not fall under a prescribed schedule could be sold and purchased without a medical prescription. This panel has sought all stakeholders’ comments and suggestions on the same. Some of the responses from pharma trade associations, as requested for, I have deliberated above. Nevertheless, the bottom-line is, nothing tangible in this regard has happened till date.

Conclusion:

As I envisage – if, as and when it happens, it is also likely to have an adverse impact on the sales and profits of many pharma players. This is primarily because, indiscriminate drug use – irrespective of self-medication or irrational prescription, do fetch good sales for them. But it shouldn’t continue any more – for the benefit of patients.

More importantly, the key argument showcased in favor of OTC drugs in India, seems to be a borrowed one – borrowed from a totally different pharma environment of the western world. Out of Pocket drug expenditure for patients, which is already very high in India, shouldn’t be allowed to go further north. Some of the India-specific intents of pharma trade associations also appear blatantly self-serving, such as total deregulation of price and promotion. It rekindles huge concerns, such as:

  • What could possibly be the key intent behind keeping essential OTC drugs outside existing price control?
  • If so, won’t it open yet another floodgate of hoodwinking price regulation of ‘essential drugs’ through crafty manipulations?

It would be a different matter though, if such OTC drugs do not fall under ‘essential drugs’ category.

Thus, in my overall perspective – ‘no price control for OTC drugs’, is an interesting demand of pharma players, but not surprising in any way – at all.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.