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Generic drugs

Sentinel Digital DeskBy : Sentinel Digital Desk

  |  24 April 2017 12:00 AM GMT

In highlighting the travails of poor people trying to decipher their doctor’s illegible prescription and then ending up buying costly medicines at drugstores, Prime Minister rendra Modi has hit upon a raw public nerve. It is being viewed as a veiled criticism of the nexus between pharma companies, doctors and drugstores — which makes a large section of doctors work like veritable agents of big pharma companies, while drugstores are only interested in stocking medicines giving bigger margins. Advertising of medicines being prohibited in India, it is this nexus pushing costly medicines down sick people’s throats. Diseases and injuries can visit us suddenly, and a significant chunk of the average household’s unplanned expenses will then go for treatment and medicines. The Medical Council of India (MCI), the apex medical regulator, has now followed up the PM’s call by asking doctors to prescribe ratiolly, go for generic drugs and write legibly. Warning medical practitioners of ‘strict discipliry action’ if they fail to toe the line, the MCI has mentioned its amended Clause 1.5 of the Indian Medical Council (Professiol Conduct, Etiquette and Ethics) Regulations, 2002, which mandates doctors to prescribe medicines by generic mes instead of brand mes. A generic drug, as defined by World Health Organization (WHO), is a bioequivalent to a branded drug — prescribed in its molecular me (paracetamol, for example). So where does the price factor come in? Generics are drugs on which patents have expired, sold either as branded or unbranded drugs under their generic mes. The conception is that unbranded generic drugs are cheaper than others. As for retail pharmacists, they are widely believed to have little incentive in stocking and selling such drugs which give them lower profit margins. With unscrupulous doctors interested in prescribing branded drugs and chemists in selling them, it is the average patient who is left short-changed.

The Union Health Ministry, Department of Pharmaceuticals (DoP), Drugs Controller General of India, the tiol Pharmaceutical Pricing Authority (NPPA) and other agencies along with the MCI are thus seeking to enforce a drug marketing code, which so far had been voluntary for chemists. This Central initiative should ideally lead to a set of laws to give consumers a fair deal on the drug price front, along with accurate information about what they are picking from the drugstore shelf. The onus will also be on State Health departments to make medical practitioners toe the line, as well as having in place a proper drug inspection and regulatory framework. When we consider a State like Assam where drug inspectors are hardly visible, the State government is sure to have a tough time in keeping tabs on chemists. There have been reports galore about many drugstores across the State operating without qualified chemists, but State governments have so far failed to weed them out. On the Central government’s part, it is reportedly revising the tiol list of essential medicines, as well as strengthen the ‘Jan Aushadhi’ network of pharmacies to supply more inexpensive generic medicines. How soon people in rural areas can benefit of these efforts, will determine the success of the PM’s initiative. With 90 percent of drugs sold in the Indian market (estimated at Rs 1 lakh crore) being of branded variety, it is clear the government has a tough challenge on its hands to go generic. A section of chemists are already beginning to resist by insinuating that generic drugs are ‘not well packaged’, and thereby of inferior quality; others are questioning the lack of quality control set-up, particularly in ensuring that generic drug makers submit bio-equivalence studies to prove the effectiveness of their products. So, if the government is to combat such fear mongering of non-branded, generic medicines being of poor quality, it will have to institute strict quality control, audits and deterrent pelties for violation of regulatory standards. All irratiol formulations and dosages need to be elimited, while essential and life-saving drugs need to be put under strict price regulation framework. It must also ensure that rogue doctors do not get to write so-called official prescriptions of generic drugs while clandestinely prescribing branded drugs. Be as it may, a public health initiative in the country has at long last begun, and needs be welcomed.

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