In September 2016, the Medical Council of India, the former regulator for medical professionals, amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002, asking doctors to prescribe generic drugs “as far as possible.”
“Every physician should, as far as possible, prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs,” it said in the new provision.
On April 17 the following year, Prime Minister Narendra Modi created a stir in the medical fraternity by indicating that a law may be introduced making it mandatory for doctors to prescribe medicines by their generic names.
Five days later, the MCI issued another advisory, asking doctors to follow the norms of prescribing generic medicines and adding that there would be provisions for disciplinary action against defaulters.
Of course, there is no parliament-backed law on this yet, nor an explanation on why it hasn’t happened. And it is common knowledge that hardly any doctor prescribes generic medicines to patients in India.
The icing on the cake is that the MCI – replaced by the National Medical Commission three years ago – has never penalised a doctor for not prescribing generic medicines.
The regulations on the professional conduct of doctors also sought to suspend their licence to practice if found guilty of accepting gifts or freebies from pharmaceutical companies. However, any conviction on these charges is unheard of in the past 20 years.
What are the factors considered when a physician prescribes medicines to a patient? Many doctors and activists say it may have little to do with science.
A drug that goes off-patent becomes a generic medicine and it could become available under an official international non-proprietary name (INPN) or a brand. The official name or INPN is the generic name of a medicine that is accepted worldwide but in India, one of the largest producers of generic drugs globally, these medicines are mostly in the form of branded generics.
After the MCI’s directives on generic drugs, doctors raised queries about how the government could ensure the quality of such medicines, concerns that persist today.
Dr Rajeev Jayadevan, a clinician and medical researcher from Kerala who is also associated with the Indian Medical Association, said that from a doctor’s perspective, the basic objective while writing a prescription is for the patient to feel better and recover.
Unless the patient improves, the doctor’s practice becomes unsuccessful, he said, adding that unlike in western countries, not all medicines available in India are of uniformly high quality.
“Only a small fraction undergoes quality checks and numerous manufacturers are known to make the same medicine under different brands,” said Jayadevan. “Fake medication is also known to be widespread. This makes generic prescribing difficult.”
Brand is king
While quality concerns may prevent some doctors from prescribing generic medicines, the pharmaceutical industry in India is allowed to operate on the basis of aggressive brand marketing.
Under the product differentiation strategy, says Dr Arun Gadre, founding member of the Association of Doctors for Ethical Healthcare (ADEH), drugmakers change a product slightly to differentiate it from those of competitors.
The companies then deploy their medical representatives to tell doctors what’s different about the product and offer them inducements, commissions and incentives to suggest these drugs to patients, he alleged.
While medical representatives should be knowledgeable about studies conducted on a drug, its safety profile, and possible side-effects, and pass on such information to doctors, Gadre says they themselves are hardly aware of such matters.
“Their only role, as of today, is to literally promote the given brands and by promoting, we mean doing all the dirty work of the companies, which is to offer incentives and keep the doctors happy by any means,” said the gynaecologist who was part of a two-member team that conducted a detailed study on the pharma industry’s influence on doctors in 2019.
When contacted for comments, the Indian Pharmaceutical Alliance, a group of research-based drugmakers, meanwhile stressed that the pharmaceutical industry is one of the most regulated industries in India and follows all the regulations & guidelines.
The industry is governed by the Uniform Code of Pharmaceuticals Marketing Practices, it said, adding that the Code addresses communication based on scientific evidence about the product and the related marketing practices.
“The companies have set up systems and processes and further undertake training of employees in this regard,” IPA said in response to a query by Moneycontrol. “The Code prescribes a procedure for lodging and handling of a complaint. IPA has set up defined processes for handling the complaint, as required in the UCPMP."
A spokesperson for the Organisation of Pharmaceutical Producers in India (OPPI), a group of MNC pharma companies, said that its member companies are committed to following the highest ethical standards in their interaction with healthcare professionals, medical institutions, and patient organizations.
The companies follow the stringent OPPI Code of Pharmaceutical Practices 2019 that, though based on the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code, is well aligned to applicable ethical norms in India.
“OPPI applauds the efforts that the government is taking in building a stronger ethical framework in the country and will continue to partner with the government on the same,” said the spokesperson. “We support these steps being taken in the right direction.”
No response was received from Indian Drug Manufacturers’ Association.
But Gadre noted that the strategy adopted by drugmakers won’t work unless the medical fraternity is their partner in the process.
“It’s not a secret that there is a crisis of ethics in the medical community but another reason why they are a solid partner to pharma companies is because they are also not regulated very well,” he said.
Dr Gurinder Grewal, who is also attached with the ADEH, said a key problem is that pharma companies treat both doctors and patients as customers.
“Freebies are offered freely to doctors and though some understand that this may be unethical, the majority gets tempted,” he said.
Malini Aisola, co-convener of the All India Drug Action Network, a patient rights group, insisted that barring a few exceptions, most doctors readily accept gifts and freebies from drugmakers.
According to Gadre, the existing NMC code has major loopholes—apart from policing problems—that allow doctors to keep working hand-in-glove with drugmakers.
“The code, for instance, allows a doctor to be on an advisory board of a pharma company and doctors’ associations to accept sponsorships from drugmakers in the name of continued medical education,” he said.
“These are some of the wide-gaping holes that provide tools to both pharma firms and doctors to exist in a perfect symbiotic relationship which is often not ethical. And then no one has ever heard of any doctor being penalised for accepting a bribe, gift or freebie.”
Former IMA president Ravi Wankhedkar agreed that as is the case with other laws in the country, implementation of the professional code of conduct for doctors remains poor.
“There should be some mechanism in place to strengthen it,” he demanded.
All this, said Wankhedkar, may be part of the larger problem that arises out of the privatisation of medical education, peer pressure, and cutthroat competition among specialists and super specialists in urban areas in the backdrop of sliding incomes, pushing some doctors towards unethical practices.
Email queries sent to NMC chairman Dr Suresh Chandra Sharma and Dr Achal Gulati, president of the commission’s Ethical and Medical Regulation Board, seeking their comments on how the loopholes are being plugged and their views on implementation of regulations were unanswered.
However, a member of the commission who did not wish to be identified, said there were very few complaints against doctors and pharma companies with specific details.
“We keep getting generic complaints from public representatives such as members of Parliament that doctors do not prescribe generic drugs or that they take freebies from drugmakers, but where are the complaints from patients?” the member asked.
According to the member, there have been 2-3 complaints over the past few years of this nature but follow-ups have been difficult for want of evidence.
“In the case of freebies, a giver and a receiver are involved with hardly any evidence to prove wrongdoing—there is little that can be done in such cases,” the member said.
The commission is preparing a new version of the code of conduct for doctors and a draft was released for public feedback in May. However, this version too does not seem to have addressed the many loopholes that activist doctors such as Gadre have highlighted.
Drug regulator, where art thou?
Gadre pointed out that it is the job of the regulator to periodically make available scientific data on the medicines based on which doctors should or should not prescribe a drug.
For example, there are many brands of paracetamol, a drug commonly used for the treatment of fever and pain. How does one deduce that paracetamol made by company A is better than paracetamol by company B? It’s a tricky question to manoeuvre for even honest medical practitioners.
This is especially important as the process of drug approval in India often does not inspire confidence.
“Due to the lack of scientific details – in the form of post-marketing surveillance data on medicines – doctors are trapped with only three options: their own belief based mostly on feedback from patients, choice of a low-cost brand, or influence by the drugmaker,” said Gadre. “Sadly, none of these is a rationale or scientific way to prescribe a medicine.”
While it may be impossible to publish the details and data of every brand, what the Central Drugs Standard Control Organisation can do, based on inputs from state food and drug administrators, is carry out periodic sampling exercises and publish the details publicly.
Moneycontrol reached out the CDSCO chief, Drug Controller General of India VG Somani, for his comments on the matter, but did not receive any reply.
Meanwhile, experts said there may be ample room for CDSCO to do better.
“As per the norms, pharma companies are required to submit post-marketing surveillance data on every drug to the regulator for a minimum of four years,” said senior pharmacologist Santanu Tripathi, who has previously served on some CDSCO panels. “But it’s only the CDSCO which can tell whether that data is received from companies or released for the benefit of doctors.”