New Delhi, April 19: Regulatory efforts to get doctors in India to prescribe medicines only through their generic names, initiated about 15 years ago, will need to overcome legal challenges and resistance from sections of doctors and the pharmaceutical industry, experts said.
Senior pharmacologists and industry analysts have also said it will be misleading to presume that prescriptions with generic names will automatically translate into lower medicine bills for patients as studies have indicated that some generics also carry high trade margins for retailers.
Prime Minister Narendra Modi had on Sunday indicated that his government might take legal steps that would require doctors to prescribe medicines only through generic names, or the chemical names of their pharmacologically active compounds.
But experts say the Prime Minister's pledge, while well-meaning, will be hard to implement and cite the failure of the Medical Council of India, the agency that regulates doctors, to enforce its own recommendation seeking prescriptions with generic names made in 2002, and again in 2016.
"This is a well-intentioned but impractical proposal - the existing drug market in the country makes it hard to implement," said Chandra Gulhati, a senior pharmacologist and editor of the Monthly Index of Medical Specialities, India. "Almost all medicines sold in India have brand names, including generic medicines with brands."
Gulhati and others point out that about 40 per cent of the estimated 60,000 drug formulations sold in India are fixed dose combinations, or FDCs, of multiple pharmacological ingredients which are only sold through brand names.
"Many FDCs contain four to as many as 40 ingredients," Gulhati told The Telegraph. "Can doctors write a prescription with so many ingredients along with their quantities (concentrations)?"
Two executives with drug industry associations said today that prescriptions with generic names only had the potential to compromise patient safety because the choice of the medicine to be handed over to patients would shift from the doctor to the retail chemist.
A spokesperson with the Organisation of Pharmaceutical Producers of India (OPPI) said the doctor-patient relationship involved "trust and faith" and was thus different from the retailer-patient relationship which was "only transactional" and likely driven by compulsions of margins retailers make.
"It becomes obvious that any such move (to make generic names only mandatory) will be compromising patient safety," T.K. Kanchana, director-general of the OPPI, said in a statement sent to this newspaper.
T.R. Gopalakrishnan, deputy secretary-general of the Indian Drugs Manufacturers Association, said when shown prescriptions containing only generic names, retailers were likely to pick the brands whose manufacturers offered them the highest margins. "This may, possibly, have health implications for patients - retailers may not always give patients the medicines that doctors want them to take."
If different brands of the same generic compounds are always pharmacologically equivalent to each other, doctors say, substitutions by retail chemists would be no cause for concern. However, some point out that studies have revealed differences across different brands of the same generic compound.
A study by doctors at the All India Institute of Medical Sciences, New Delhi, published this month in the journal International Opthalmology has found "significant variations in drug concentrations and physical properties" of generic formulations of latanoprost, a medicine used to treat glaucoma, an eye disorder.
Some doctors who have tracked the pricing of drugs have cautioned that the trade margins for branded generic medicines are at times even higher than the margins for branded medicines from the same companies.
A 2010 study that had examined five drugs - an anti-allergic medication, an antibiotic, an anti-anxiety drug, an anti-depressant and a drug used to treat stomach ulcers - found that the margins for retail chemists ranged between 25 to 30 per cent for branded versions and 200 to 1,000 per cent for branded generics.
"Such huge profit margins to retail chemists will completely negate any possible gains to consumers," said Anita Kotwani, professor of pharmacology at the Vallabhbhai Patel Chest Institute in New Delhi who had conducted the study. "We need greater transparency in the margins of profits made along the drug distribution channels - from the manufacturer to consumer, who makes what margins? Consumers need to know that," Kotwani said.
Patients' rights advocates have long urged the Union health ministry and the Union department of pharmaceuticals to impose price caps on medicines based on their manufacturing costs and abandon the existing formula that relies on the average market prices of some drugs.
"This would be the only effective route to lower prices," Gulhati said. "Besides, all medicines, not just a few, should be brought under price control."
The cost-based pricing mechanism imposes maximum prices by taking into account the actual production costs allowing for reasonable margins for companies and distribution channels. The averages formula tends to increase the prices in favour of the more expensive drugs.
The Indian Medical Association (IMA), a body of private doctors, said in a statement on Tuesday that the association "feels there is no need for new legislation to ask doctors to prescribe generic drugs".
"The Medical Council of India's etiquette for doctors already stipulates this," IMA president Krishan Aggarwal said.