The regulations concerning medical education and professionals, announced on August 2 and then held over, may be back soon, albeit diluted, said industry insiders.
The rules, laid down by the National Medical Commission (NMC), mandate doctors to write only generic names in prescriptions (not brand names) and also say registered medical professionals and their families must not receive any gifts, travel facilities, hospitality, cash or monetary grants, consultancy fees or honorariums from pharma companies, those manufacturing medical devices, or corporate hospitals on any account.
They seek to debar registered medical professionals from attending seminars sponsored by pharma companies.
The regulations have created consternation among medical professionals. The Indian Medical Association (IMA), the apex body of Indian medical professionals with around 400,000 doctors, has met senior government officials in this regard.
In its letter to the Union Health Minister Mansukh Mandaviya on August 21, the day the abeyance came into effect, the IMA said: “(The World Health Organization) and Schedule M of Drugs and Cosmetics Act, 1947, provide a comprehensive set of guidelines. The most important characteristic of any drug is its Bioequivalence (BE) and Bioavailability (BA) to the innovator product to prove its safety, clinical efficacy equivalence and cGMP compliance on continuous basis for sustainable supply. Currently only a few categories need BA/BE study. All generics may not be bioequivalent.”
It said: “There (is) no government or statutory funding of the CME (continuing medical education) activities in the country. There is little doubt that the sponsors of CMEs, i.e. pharma companies, hospitals etc plough back their earnings into the society by providing opportunities to enrich knowledge and information. So long as individual personal gains are not allowed, professional associations are the best bet to handle this responsibility on behalf of patients.”
Doctors and pharma companies argue if branded generic names are not allowed to be mentioned, there can be issues on the quality of the prescribed drugs because there is no uniform drug quality across the 10,000-12,000 pharma units in the country.
Moreover, they say such a move may result in medical representatives losing jobs. There are around 250,000 medical representatives in India, and around 500,000 people are associated with pharma marketing and sales.
Patient advocacy groups, however, are upset at the possible dilution of the regulations.
Malini Aisola of the All-India Drug Action Network told Business Standard: “The NMC regulations were trying to introduce a better prescribing culture and move towards more rational treatment. Writing medicines in generic names, with or without mentioning brands, would still be a step in the right direction. In fact the clause disallowing sponsorship for continuing medical education closed many loopholes in the Medical Council of India (MCI) code and was the bigger threat to disrupting the cushy relationship between the medical fraternity and industry.”
She added: “The Union health ministry worked behind the scenes to ensure the entire regulations were put in abeyance … It would be a huge setback if the NMC regulations are not reinstated.”
The ministry did not respond to an email sent on the matter till the time of going to press.
Industry sources said the regulations would be back within a month or two, though in diluted form.
“There will be specific penalties for doctors … doctors may be allowed to write brand names along with generic names and third-party sponsorship of events may be barred,” said an industry source.
This will set the tone for the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) to be made statutory, he said.
Milind Antani, leader, pharma and health care practice, Nishith Desai Associates, said: “Under the MCI Code, prescribing drugs by their generic names was advisable, but that was at the doctor’s discretion. The intent in the NMC Code was for doctors to mandatorily prescribe drugs by their generic names except in exceptional circumstances. Failure to do so may lead to the licence to practise getting suspended for up to one month.”
Do medical representatives regularly visit doctors with valuable gifts?
A veteran pharmaceutical sales and marketing executive told Business Standard medical representatives almost never did so. “They present what we call table-top items with our branding. These hardly cost more than Rs 500,” he said.
“But when it comes to obliging senior doctors, they are done in ways other than expensive gifting,” the executive added.
He said some decades ago, most of the conversation medical representatives had with doctors was on new medicines being launched, and token gifts such as expensive pens were given. Pharma companies then came up with the concept of medical conferences, and doctors (often accompanied with their families) were sent on international trips. Things went downhill, and even cash transactions or valuable gifts like televisions, refrigerators, cars, and even apartments became common if a doctor was prescribing a certain brand, the executive said.
Sharad K Agarwal, national president of the IMA, told Business Standard doctors could charge a consultancy fee for their time and knowledge sharing.
“Don’t chartered accountants or lawyers do the same thing,” he asked.
The Federation of Medical and Sales Representatives’ Association of India (FMRAI) said reviewing the pricing policy was enough to reduce prices of medicines substantially.
Ramesh Sundar, president, FMRAI, told Business Standard instead of focusing on generics, the government needed to come up with a cost-based formula for fixing drug prices. Business Standard