New treatment: NMC regulations, albeit diluted, likely to be back soon

Agarwal adds that at a CME the speaking doctor is merely sharing his experience of using a particular molecule; never does he mention a particular brand

At a cardiologist clinic in the eastern suburbs of Mumbai, a narrow alley leading to the clinic is crowded with medical representatives (sales force) from various pharmaceutical companies. Some of them have been waiting since morning, enduring the occasional drizzle well past lunchtime.

"The doctor usually gives us time, often less than a minute, after he finishes checking his patients. He is a key opinion leader (KOL) in the area, and since there have been several launches of heart failure medications following patent expiry, we have come to meet him," says a medical representative from a Mumbai-based firm, speaking anonymously. He adds that there have been over 50-60 new brands flooding the market – the same molecule, same potency, but at different price points. "We often meet the doctor to ensure there is a top-of-mind recall for our brand," he adds.

So, does the doctor prescribe because the MR meets him regularly? At least four or five MRs waiting for their turn at the clinic said there was no assurance of that. "This particular doctor writes both generic names and brand names. He usually prints out his prescriptions, and there is no one particular brand he favours. He prescribes different brands from time to time," say one of them.

A company that recently launched the same molecule – sacubitril-valsartan combination – is conducting a patient screening for diabetic neuropathy at the clinic. It has put up branding around the screening, and senior citizens are queuing up for the free screening.

Do MRs regularly visit doctors with valuable gifts? A veteran pharmaceutical sales and marketing executive tells Business Standard that MRs almost never visit with expensive gifts. "MRs would present what we call table-top items with our branding. These items hardly cost over Rs 500," he says. "But when it comes to obliging senior doctors, that is done in ways other than expensive gifting," the executive adds.

He recalls that in the 1980s, most doctor-MR conversations revolved around new medicines being launched, and token gifts like expensive pens were shared. Pharma companies then introduced the concept of medical conferences, and doctors, often accompanied by their families, were sent on international trips under the pretext of such conferences.

However, things have changed in the last seven to eight years. "There is much more scrutiny now, and senior doctors are often not interested in valuables," he says.

Doctors often associate with pharma companies as advisors, serve on ethics committees for clinical trials, and charge hefty fees. Pharma companies sponsor conferences organised by doctor associations known as continued medical education (CME), and speaker doctors are paid fees. Often, this is done through third-party arrangements where a travel agency raises a bill.

"Recently, a well-known pharma company in Mumbai faced legal trouble for paying for attendees, who had come to attend a conference, to stay at a five-star hotel. They had routed the payment through the hotel as banquet charges," says another former pharma company executive. He adds that companies are not supposed to pay for the stay (other than for speakers) of attendees at any hotel, and thus the company had routed it differently. "But there is always a trail, and thus companies have become cautious," he adds.

He says that doctors are often keen to publish their write-ups in renowned journals, attend prestigious seminars with marquee global research institutes, or be part of advisory committees with pharma companies or even the government. "These actions are also obliging to the medical professional, but it's not as crude as giving an expensive gift," he adds.

Sharad K Agarwal, national president of the Indian Medical Association (IMA), the apex body of Indian medical professionals with around 400,000 doctors, tells Business Standard that as professionals, doctors can always charge a consultancy fee for their time and knowledge sharing. "Don't chartered accountants or lawyers also do the same?" he asks.

In its letter to the Union Health Minister Mansukh Mandaviya on August 21, the IMA had said: There are no government or statutory funding of the CME activities in the country. There is little doubt that the sponsors of CMEs i.e. the 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 the professional Associations are the best bet to handle this responsibility on behalf of the patients.” It had added that the best way to spend part of pharma profit for patients is to allow them to sponsor CME activities of professional associations.

Agarwal adds that at a CME, the speaking doctor is merely sharing his experience of using a particular molecule and never mentions a particular brand.

The National Medical Commission (NMC), a government body regulating medical education and professionals, issued fresh regulations on August 2, which were held in abeyance on August 21. Among other things, the NMC regulations had mandated doctors to write only generic names in prescriptions (not brand names) and also said that registered medical professionals (RMPs) and their families must not receive any gifts, travel facilities, hospitality, cash or monetary grants, consultancy fees, or honorariums from pharma and medical devices companies, corporate hospitals under any pretext. RMPs were barred from attending seminars sponsored by pharma companies.

The regulations ruffled feathers, and the pharma lobby, the IMA, met senior government officials. Both doctors and pharma companies argued that if branded generic names were not allowed to be mentioned, there could be issues around the quality of drugs, as there is no uniform drug quality across the 10,000-12,000 pharma manufacturing units in the country. Moreover, they reasoned that implementing such a move may result in significant job losses for MRs. There are around 250,000 MRs in India, and approximately 500,000 people are associated with pharma marketing and sales.

“WHO and Schedule M of Drugs and Cosmetics Act, 1947 provides a comprehensive set of guidelines. The most important characteristics 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,” IMA had said in its letter to the health minister.

Patient advocacy groups, however, are upset with the NMC regulations being put on hold. Malini Aisola from the All-India Drug Action Network tells 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 mention of 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 cosy relationship between the medical fraternity and the industry."

She adds: "It would be a huge setback if the NMC regulations are not reinstated." The Union health ministry did not respond to an email sent on the matter. 

 

Industry sources, however, claim that the NMC regulations will be back within a month or two, albeit in a diluted form. “There would be some specific penalties for doctors, unlike the MCI code; doctors may be allowed to write both brand names along with generic names; third party sponsorship of events may be barred,” said an industry source. He added that this would set the tone for the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) to be made statutory.

Dr Milind Antani, leader, pharma and healthcare practice, Nishith Desai Associates said that, “Under the MCI Code, prescribing drugs by their generic name was advisable, but at the doctor’s discretion. The intent of NMC Code was for doctors to mandatorily prescribe drugs by their generic name except in exceptional circumstances. Failure to do so may attract suspension of license to practice for up to one month.”

The Federation of Medical and Sales Representatives’ Association of India (FMRAI) says that reviewing the pricing policy is enough to reduce the prices of medicines substantially. It noted in an editorial piece on FMRAI News September 1 issue, that the logic floated in favour of generic names is that generic drugs are cheaper as marketing expenses are not involved.

“An average of the MRPs of the most prescribed brands is taken and then that becomes the upper limit of the price of the controlled drug! This arrangement ignores the fact that in India because of various reasons, the brands that sell most are also priced the most!” the FMRAI News editorial said.

Ramesh Sundar, president, FMRAI told Business Standard that instead of this focus on generics which may raise serious concerns around uniform quality, the government needs to come at a cost of production based formula for fixing drug prices.

“This would automatically curtail the marketing expenses for a brand. Whatever is the cost of production, adding the distribution, logistics among other costs and a margin, the MRP can be fixed,” he suggests. The industry says that the cost of marketing and promotions is about 20 per cent of the medicine’s price.

Whether the NMC Regulations are brought back is to be seen, but the practice of MRs visiting doctors is unlikely to go anytime soon.