Rx: Generic drugs!

The latest government’s order on prescription of even generic drugs mandatory shall be a welcome move. The new order makes it clear that all doctors must prescribe generic drugs, failing which they will be penalised and their licences may even be cancelled. The National Medical Commission (NMC) in its ‘Regulations Relating to Professional Conduct of Registered Practitioners’ also cautioned the medical practitioners not to prescribe banded drugs. This may come handy for the Indian pharma industry to grow and make the concept of ‘generic drugs’ more meaningful as it was meant to make medicines affordable to the poor and needy. Although in the past some state governments like Karnataka indeed made an effort to ensure Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations 2002, it had no visible takers among the doctors’ community, reasons best known to them.  This clause clearly states that every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.

However, the clause was modified on September 21, 2016 (No. MCI 211(2)/2016(Ethics)/131118) and notified in the Gazette of India on October 8, 2016 and reads as follows: “Use of generic names of drugs: Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.” It was in 1970, the Food And Drug Administration (FDA) the established the Abbreviated New Drug Application (ANDA) as a mechanism for review and approval of generic versions of the drug products that had been approved between 1938 and 1962 (Henderson, 1992). For example, a brand name and generic drugs can be cited with diabetes and hypertension drugs. Metformin is a generic drug for diabetes, but its brand name is Glucophage. Similarly, Metoprolol is a generic drug for hypertension but its brand name is Lopressor. Assume for the moment that the MCI and the government spokespersons intend doctors to prescribe drugs by their generic names where “generic” is broadly defined when the patent on the drug expires. In that case, it would become illegal for a brand to be prescribed. How can multinational drug companies be permitted to market their brands in India if doctors in India are not allowed to prescribe these brands? The situation becomes paradoxical and is bad in law.

Ironically, none of these official directives define the term “generic drug” or prohibit the inclusion in the prescription of a trade name of a branded generic. Therefore, these directives are ambiguous and do not serve their intended purpose. As important as the definition of profit is the definition of what is brand and what is generic. There is no controversy that a drug is a brand when it is marketed under a trade name by the company that holds the patent on the drug; this is applicable even if the patent on the drug has expired. As a slight digression, sometimes, a company that held the original patent may sell the drug along with the patent to another company, and some drugs may in this way pass through several hands before they reach the market. Vilazodone is an example of one such drug. In such cases, the brand is the version that belongs to the company that first brought the drug to the market.

Hence, there is no controversy whatsoever that a drug is generic when it is supplied, usually in bulk and to hospitals, under a pharmacological name rather than a trade name. Yet, where controversy arises is on what to call a drug that is supplied under a trade name by a company that is not the originator company, after the patent on the drug has expired. In most parts of the world, especially in developed countries, this controversy does not exist. The drug marketed by the patent holder is de facto the brand, and all other versions of the same drug, marketed by one or more other companies (once the patent on the drug expires), are generics. Given that multinational pharmaceutical companies generally do not venture into the generic market space, and given that Indian pharmaceutical companies have few to no original drugs in the market, this means that all or almost all drugs marketed in India by multinational companies are brands, and all or almost all drugs marketed in India by Indian companies are generics.

Added to that is the fact brand-name manufacturers spend loads of money on marketing new drugs to doctors and the public. They try different tactics for providing a place for their drug in the market. The brand name manufacturing firms send their representatives to visit the doctors in their clinics and various hospitals; these companies also invest in arranging conferences to talk about their drugs with other doctors. Generic manufacturers rarely spend money on advertising and marketing. Against that backdrop, it is loud and clear why a physician opts to prescribe the brand drugs instead of generic ones. If the government shall understand this simple fact and come up with more stringent laws to ensure the prescription of even generic drugs mandatory by physicians, if they wish to. Yes, by enforcing the law more effectively by suspending licences of those physicians who refuse to prescribe the generic drugs, which help poor patients immensely and also impose heavy penalties. Only such harsh decisions will ensure to accomplish the concept of providing expensive drugs to the poor and needy at affordable prices. Often, the non-generic pharmacies openly mislead the patients about the efficacy of generic medicines and brainwash them to go for branded ones, which are, needless to say, costly. This make the poor patients scared and go in for costlier medicines, which they can ill-afford. This is something which needs to stop and that can happen when the government is strict and insists on doctors to compulsorily prescribe generic drugs. Let people be put at comfort levels and choose either generic or non-generic as per their affordability. They need to be convinced that both the medicines work effectively. And, the NMC move was in right direction and hopefully, it will discipline the erring medical practitioners, who made this pious profession more commercial than empathetic.