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Generic prescription – will it solve the real issues?

Guru Prasad Mohanta & P. K. Manna
Wednesday, May 10, 2017, 08:00 Hrs  [IST]

Following the prime minister’s stress on use of generic name in prescription, there have been lot of activities at government levels to make this a success. It is not that the first time efforts are made on promoting prescribing in generic name, but perhaps a major decision after the demonetization. The prime minister has cautioned the possibility of a legal framework to ensure compliance by the doctors.

The medicines are available in three names: common name (generic name), branded generics and brand names. The brand name in true sense, is the name given by the innovator company who holds the patent. On expiry of patent period, the drug molecule is free to be manufactured by other companies and sell them in generic name. The medicines available as generics after the expiry of patent must be bioequivalent so that they can be interchangeable. These generics are cheaper than the brands. So, there is no differences between the generics and their brands except the price. The branded medicines are priced at higher level because the pharmaceutical companies spend substantial amount building the brand value. There are few innovators’ brand (patent medicine) in Indian market. It is believed to be around 7 per cent. Most of the pharmaceutical market is dominated by the branded generics accounting for about 70 per cent of the market. This is something unique to India where the off patented drugs sold in brand names called branded generics. As far as pharmaceutical market is concerned, there is no difference between brands and branded generics. Both groups are sold in brands only.  The common name or generic name is the name of the drug molecule for which no ownership exists. This name for a molecule is given as International Non-Proprietary Name (INN) by the World Health Organization. At present, mostly the generic names are used to procure medicines in government sectors.

The medicines are different types of commodities than other essential items of daily use at least on two counts. First, they are capable of harming the user if not used properly. Hence, there is regulation for everything from approval of new molecules to their sale. The engagement of service of a registered pharmacist is mandatory for retail sale, though not enforced strictly. Second difference is the customers of medicines. There are direct and indirect customers: prescribers/dispenser and patients. The patient are always at the receiving end. They pay for their medicines but they have no say which brand or which generic is to buy. The doctors who prescribe decide or the chemists decide when the patient or their representative directly approach them. This is the point of concern in use of brands or generics in prescription writing. Over prescription is often said “It is not that the patient needs these prescribed medicines, but the prescriber needs to sell them”.  Perhaps there is another angle too. The way the medicines are marketed. The medical or sales representatives uses various tools which may be grouped as 5 C’s (convince, confuse, coax, corrupt, and cry). These add up the cost of the medicines.

The generic prescribing is proved to have several positive points. It avoids the medication errors both at prescribing points and dispensing points. It would most likely reduce the medication cost in a drug therapy. The likely word is used because there are several concerns on generic name prescriptions. There are several companies making generics or branded generics. The prices vary widely at least for drugs which are not under the domain of price control mechanism. In such cases, which one the pharmacist would dispense. It is obvious that the variety which gives the maximum profit would be the choice for the pharmacist. The choice of brand just gets shifted from the doctor to the chemist, the drug seller. Some studies have reported higher maximum retail price of generics than the banded generics.

The Medical Council of India has suddenly woke up to recirculate the provision of use of generic name in Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations 2002 as amended in 2016. The provision says “Every physician should prescribe drugs with generic names legibly and preferably in capital letter and he/she should ensure that there is a rational prescription and use of drugs”. Circular further threatens that the violation of the provision of generic name prescribing invites disciplinary action. Similarly, Ministry of Health and Family Welfare of Central government has sent circular to all State governments emphasizing the compliance with gazette notification of Medical Council of India’s regulation of prescribing in generic name. Other state governments too tried to implement this earlier. One such example is Chittorgarh experiment where the then collector asked the doctors to keep the carbon copy of the prescription to ensure that the prescriptions are written in generic names only.

There are many hurdles in promoting prescribing in generic names. Besides giving more importance of pharmacology and medicines’ name during teaching medical graduates, it is necessary to build public confidence on generics’ quality. The quality is not a big challenge now. The recent report of countrywide quality testing confirms that the number of substandard drugs produced and sold in India at 3.5 per cent, much lower than the proportion of not-of-standard-quality medicines elsewhere in the world. Quality is not the issue of generics only, recently the Government of India reported several branded generics, house hold brands, are not of standard quality. But onetime testing would not help but definitely a beginning. The more frequent quality checking would build the confidence among the consumers, the prescribers and the dispensers. In addition, government needs to ensure the bioequivalency of all generic versions or branded generics to make them confidently interchange.  More public generic stores within the rich of the people is also necessary. The sincere efforts to implement the mandatory prescription in generic name would also wipe out other ills like the presence of large number of irrational combination medicines for which there is not generic name.


(Authors are with Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu – 608 002)

 

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