Indian Drug Manufacturers' Association (IDMA) is of the opinion that the products to be sold through OTC route should an absolute minimum as the country does not have the required infrastructure nor qualified pharmacists. Low literacy and education amongst the consumers of medicines also makes it all the more necessary to be extremely cautions on this front.
In an effort to tackle the issue an expert committee formed by IDMA worked out a draft proposal on the problems of expanding OTC drug list and submitted to the DCG (I) on 28th October 2005. The following is the text of the proposal.
OTC SCENARIO
In India the prescription drugs are listed under Schedule H. There are about 570 molecules in this category that are stocked in a total of 5 to 8 lakh retail chemists. Currently, non pharmacy stores can sell a few drugs on the Schedule K of the Drugs & Cosmetics Act in rural areas in villages whose population is below 1,000.
CODE OF STANDARDS FOR ADVERTISING OF MEDICINES AND TREATMENT:
1. Rule 106 of the Drugs Rules, 1945, provides that, no drug may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments specified in Schedule J. This schedule includes: Blindness, Bright disease, cancer, cataract, deafness, delayed menstruation, diabetes, epilepsy, hydrocele, infantile paralysis, leprosy, leucoderma, lockjaw, locomotor ataxia, insanity, tuberculosis, tumours, venereal diseases (in general), female diseases (in general), fevers (in general ), fits, glaucoma, goiter, gonorrhea, soft cancer, heart diseases, high blood pressure, lupus, obesity, paralysis, plague, rupture, sexual impotence and small pox.
2. No drug may purport or claim to procure or assists to procure or may convey to the intending user there of any idea that it may procure or assists to procure miscarriage in women. Thus drug or formulation meant for any of the conditions as listed in Schedule J is not suitable and to be permitted for marketing it as OTC.
In 2005 the Indian OTC segment is Rs 4500 crore it could be considered as Rest 17000 cores if cosmeceuticals & neutraceuticals are also included. The global OTC market is projected to be USD 75 billion (roughly INR 375,000 crore) with a cumulative annual growth rate (CAGR) of 4.5%. The CAGR for Indian OTC markets is currently hovering between 12 and 15% and this is much faster than OTC market growth of most development countries.
Due to changing trends and consumer awareness, the OTC market is contemplated as future growth driver. Besides India has the lowest per capita medicine spend of USD 0.5 vis-à-vis USD 55 for USA.
The present low per capita medicine spend coupled with the fast growth of Indian OTC market is the basis on which the MNCs are pushing forth measures to enhance the OTC market - basically by increasing the number of drugs that could advertised.
Recently, the Organization of Pharmaceutical Producers of India (OPPI) has submitted a list of 11 molecules to the Drugs Controller General (India) (DCGI) to be excluded from Schedule as part of its campaign to expand OTC segment.
In early 2004, the government had shot down the MNC drug companies' demand for permitting OTC sales for over a dozen categories of drugs that are apparently considered household remedies. The Drugs Technical Advisory Board (DTAB) had taken a view that medicine retailing scenario in India is considerably different from the west, where popular drugs are allowed to be sold over the counter by super markets that have proper storage facilities.
In India, Good Pharmacy Practices (GPPs) are not followed by majority of the chemist shops, let alone the other outlets which could technically stocks OTC medicines. Bad storage, non compliance with the date of expiry and wrong advice on dosages can be extremely harmful to the consumer- patient. The problem is not only of precipitating serious side effects leading even to fatality, but that of meeting specified bioavailability and bioequivalence criteria of drugs, the sources said. Even an iron preparation can be toxic in normal doses, as improper storage can lead to oxidization.
The government also thinks that with over 7 lakh retail medical stores in the country-- which means roughly one store for 1500 people --the infrastructure for dispensing medicines is too insufficient. This defeats the very premise of OPPI's arguments that more drugs be in OTC list so as to facilitate their wider availability as far as adherence to prescription norms is concerned. It is common knowledge that unlike in developed countries Indian chemists are not too strict with respect to having a written prescription.
IS HEALTHCARE SEGMENT MATURED ENOUGH FOR OTC EXPANSION?
Prescription-based drugs rely heavily on doctor detailing. It is a direct marketing tool used successfully over the years to explain the formulation and bene-fits of a drug to the concerned patients.
Though the Indian pharma industry is still restrained from any mass advertising, 'direct-to-consumer' (DTC) advertising in pharmaceuticals marketing is a revolutionary concept fast catching in the US and other developed countries in the West. The objective of DTC advertising of prescription medicines is to enhance consumer knowledge about diseases and treatments, mainly amongst the informed public.
DTC helps to generate a dialogue between the patients and the doctors. The benefit of such a medium is not purely aimed at the doctor prescribing drug when the patient asks for it. However, it will certainly prompt a discussion around symptoms leading to diagnosis and then prescription of the right medical aid. All this will no doubt lead to a better understanding and treatments of the patient's condition.
The US FDA has been sensitive to the need of patient education, and has permitted DTC advertising in mass media. Can this be replicated in India? A country with a large illiterate population cannot really benefit in totality by DTC advertising for technically prescription - based drugs. Moreover, such advertising has to have adequate safeguards to avoid inappropriate use of medicines.
REQUIREMENTS FOR OTC MARKETING
For any product to be sold as OTC, it must fulfill the following three criteria:
- it must be safe.
- it must be effective.
- it must be for a condition that the patient can manage without supervision by a licensed health professional.
Any drug which is to be shifted from Schedule H to OTC category is naturally expected to be effective. The concerns would however be its safety and issues pertaining to unsupervised intake.
SAFETY OF DRUGS IN PROPOSED OTC LIST
OTC products can cause side effects, drug interactions, and disease interactions. These medicines may worsen the existing condition or they may cause another drug that is taken to build up in body possibly resulting in side effects, akin to when it is taken in excessive dose.
The use of drug such as NSAIDs, gastrointestinals and prochlorperazine in particular, would thus be dangerous as OTC medicines knowing the various side effects and restriction associated with their routine and long terms use.
SUPERVISION OF OTC DRUGS
A key issue in OTC drugs marketing is dispersing information pertaining to their safe usage. As these drugs will be taken without any medical advice, label claims with regard to disease symptoms, directions for use, warnings, etc. is extremely important.
The issues pertaining to OTC drugs' safe usage are many in India:
- Drastic change in the labeling practices of DTC medicines have to be compulsorily enforced if they have to be sold outside medical shops. Firstly, labeling of OTC medicines has to be in local languages and all the instruction have to be in simple and easily understandable words. At present, very few pharma companies are printing labels in local languages.
- Generally labels on OTC products also do not indicate specified doses for children. It has to be ensured that all OTC drugs specify the correct needs for children in terms of quantities, frequency and duration of their intake.
- Some basic knowledge about medicines is also crucial amongst the traders who will be selling OTC products. This is an unachievable task knowing fully well that qualified pharmacists do not continuously man the chemist shops selling OTCs, let alone knowledgeable sales force educating customers in other than chemists stores stocking such products.
In absence of safe guards to facilities safe selling of OTC products, the inclusion of NSAIDs like ibuprofen, mefenamic acid, ketoprofen & dictlofenac, gastrointestinals especially such as domperidone and loperamide, as well as prochlopreazine in particular, in the already existing non - prescription category is besieged with lurking dangers.
LACK OF INFRASTRUCTURE, SAFETY ISSUES DEFEAT PURPOSE
OTC products must primarily be safe. They should never have been known to cause frightening side effects, must be relatively safe in overdose, and also for the pregnant ladies, nursing women, and small children. Besides, these medicines are best stored in chemists' shelves since the Indian general stores, and those in shopping malls and plazas, are not geared up for such OTC products handling.
This defeats the very purpose of shifting more products to the OTC category. If availability is to be continued at chemists counters, it must be the prerogative of medical profession to dictate the use of the medicines under question. Doctors are knowledgeable about the OTC drugs potential to cause side types. Hence, they are best placed to judge the situations under which individual medicines must be avoided, and to tackle all patients' query. Marking available an array of Schedule H drugs as OTC could possibly question indirectly the wisdom of the trusted family doctor by this patients when the latter needs to prescribe the very product which otherwise are available off the shelf easily.
WHY NEW DRUGS WHEN ALTERNATIVES ARE AVAILABLE?
- NSAIDs : Why four to five new Schedule H NSAIDs to be included in the list when paracetamol is OTC for similar usage?
- For diarrhoeas suitable options such as ORS are recommended as first line and are available. Then, why should loperamide be considered as OTC ?
- In cough & cold segment instead of bromhexine, suitable cough-cold formulate are already advertised. Even adhatoda vasica, from which bromhexine is derived, is available as OTC.
- Prochlorperazine is unthinkable as OTC. We already have suitable options to manage the various causes of vomiting such as antacids for gastritis associated vomiting etc.
In view of the above realities, it is ideal to stick to existing list of OTC drugs, especially if suitable and safe alternatives for that indication already exist.
- (Courtesy: IDMA Bulletin)