Pharma industry in a huddle after fresh NMC regulations for doctors

With the National Medical Commission (NMC) making it mandatory for doctors to prescribe generic names for drugs, pharma-industry groups are in a huddle over questions of quality and safety.

A senior executive of a prominent lobby group said the fresh regulations were being examined. “If doctors prescribe only generic molecule names, then there may be an issue with quality. With a branded generic there comes a quality assurance and thus this is critical for patient safety,” the person said.

“There are over 10,000 manufacturers of medicines in the country, and not all of them follow the same quality guidelines. Therefore, with such a move, who takes responsibility for quality and patient safety – will the doctor be accountable?” he added.

Further, once the doctor prescribes the molecule name, the chemist will choose which brand to give the patient, said pharma industry insiders.

“Power thus shifts to chemists instead of doctors. Whichever company offers better incentives, the chemist would prefer it,” the industry feared.

Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists (AIOCD), an umbrella organisation of chemists in the country, said: “We find some challenges and concerns with this government’s decision for generics. There’s concern about potential monopolies by big companies in the future.” 

He expressed concern about quality. “Substandard stuff has been found even among branded drugs sometimes.” 

Singhal said making generics optional could help prevent monopolies and protect patient rights.

However, this approach might also impact the pharmaceutical industry and the availability of branded drugs.

The revenue of the pharma industry may decrease and this could affect research and development. And some patients might worry about the effectiveness of generic drugs, he added.

Trade margins for drugs are fixed – 10 per cent for wholesalers and 20 per cent for retailers (chemists). However, smaller companies are known to offer better margins for their medicines, which they don’t push through doctor prescriptions but through trade. These are known as trade generics. Now big pharma companies are also stepping up their game in this segment.

The NMC in its regulations said all doctors “must” prescribe generic drugs, or else they would be penalised. Even their licence to practise may be suspended for a period.

The NMC issued the “Regulations relating to Professional Conduct of Registered Medical Practitioners” on August 2.

It says: “Every RMP (registered medical practitioner) should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.”

India is a branded generics market where companies make generic or copy-cat versions of a drug that has lost its patent, and sell them under several brand names. For example, paracetamol can have hundreds of brand names. The NMC has asked doctors not to prescribe branded generic drugs.

Industry insiders say this is a step towards implementing and codifying the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).

“At the moment the UCPMP is a voluntary set of guidelines preventing pharma companies from giving freebies to doctors, but it falls upon pharma associations to enforce the code,” said a senior executive of a pharma firm.

Another person who is also a member of a pharma lobby group said firms regulated themselves. “We want unethical practices to stop. But since the code is not legally implemented, we don’t have any powers to take action against any firm who violates the UCPMP. The NMC regulations had to be in tandem with the UCPMP, and this a step in the right direction,” the person said.

Doctors said the guidelines were a welcome step.

Shuchin Bajaj, founder and director, Ujala Cygnus Group of Hospitals in Delhi, said: “The new NMC guidelines on generic drugs are a welcome step in the direction of bringing down health care costs and improving access to quality care in the country.”

“The regulations have asked doctors to avoid prescribing branded generic drugs, which may be less costly than the branded patent version but costlier than the generic version of the drug that is manufactured in bulk. Doctors should take it as an ethical responsibility to prescribe only those generic medicines available in the market and accessible to patients,” Bajaj added.

Apart from asking doctors to prescribe generic medicines, the NMC has cracked down on RMPs receiving freebies from health care establishments or pharma companies. Moreover, for the first time  NMC guidelines restricted doctors from speaking on subjects beyond their area of expertise on any public platform, including social media.

What’s changed

The new National Medical Commission (NMC) regulations say:

Doctors should prescribe generic drugs, failing which would attract penalty
 

Doctors should not speak on subjects beyond area of expertise on any public platform
 

Registered Medical Practitioners (RMPs) and their families should not receive any gifts 
 

They should also not attend seminars, conferences, which involves direct or indirect sponsorships from pharma firms