Last Monday PM Narendra Modi announced that government is planning to bring in a legislation that will make it mandatory for the doctors to prescribe the generic names of the medicines. The move has been heartily welcomed by public as it’s seen as the much needed step to break the infamous Pharmaceutical companies-Doctors nexus and to make the medicines affordable for a common man. But it’s misleading to assume prescriptions with generic names automatically translate into quality medicines at cheaper price for patients.
The branded drug product is originally discovered and developed by a pharmaceutical company. After the patent life of the drug expires, it is eligible to be manufactured by other companies and then it becomes a generic drug. The generic drug manufacturers are supposed to ensure that generic drugs have same active ingredients in the same concentration and same dosage forms as the original branded drug.
In India, there are very few patented medicines. The most drugs sold in India are generic but they are marketed under a brand name given by the manufacturer. The proposed law will pass the onus of selecting the brand name of drug and manufacturer to the pharmacist. It will put the health of patients in the hands of pharmacist instead of the doctor.
A 2010 study in Indian Journal of Pharmacology compared retailers’ profit margin on five commonly used drugs -cetirizine, fluoxetine, ciprofloxacin, lansoprazole and alprazolam. The retailer margin for five branded medicines they studied was in the range of 25%-30%, but for their branded-generics version manufactured by the same company it was in the range of 201% -1000%
A high level panel headed by Sudhansh Pant, joint secretary in the department of pharmaceuticals, and included representatives of the National Pharmaceutical Pricing Authority, Competition Commission of India and industry bodies was set by PMO to study increasing price of generic medicines in 2015. According to newspaper reports, the panel found out that retailers that profit margins of these manufacturers vary between 100 per cent to even up to 3,000 per cent on the Maximum Retail Price.
It suggests that push for prescribing generic names will stop doctors from favouring particular companies but now pharmacist will sell medicines which gives them better profits. To break the Pharma Companies-Doctor link, government is paving a way for Pharma Companies-Pharmacists nexus.
India is a home to more than 125 FDA approved pharmaceutical manufacturing units and exports around 400 billion INR worth of drugs across the world. India accounts for almost 22% of the global generic drugs market and its share is rapidly increasing but India do not have legal framework to maintain the quality control.
There is absence of clear and uniform interpretation of GMP (Good Manufacturing Practice) guidelines given by WHO. The national drug regulator – Central Drugs Standard Control Organization is inefficient, under-equipped and highly understaffed. There is no consolidated national list of manufacturers or total number of licences granted which makes it difficult to design any solid national policy for the sector.
Several major Indian pharmaceutical firms have been caught selling inferior and potentially dangerous medicines abroad. U.S. National Bureau of Economic Research examined nearly 1,500 India-made drug samples collected from 22 cities of Africa and found that 10% of the antibiotic and anti-tuberculosis samples contained insufficient levels of the key active ingredients. Those drugs weren’t counterfeit but didn’t contain enough active ingredients to actually treat the disease. That means patients were wasting their money. The medicines wouldn’t make them better but substandard medicines can cause the drug-resistant diseases.
So, PM Narendra Modi’s well-intentioned push for generic names on prescriptions does not fit in the incompetent drug regulatory system of our country which is struggling to ensure quality medicines from all manufacturers. Once the regulatory infrastructure is equipped with adequate manpower and facilities, this directive can be implemented.
Writer : Ekita (@LostByWaves )