Manish Kumar, a student living in Delhi decided to buy the monthly medicines for his diabetic mother from a Janaushadhi store in Munirka instead of the neighbourhood chemist. Life was getting expensive with inflation hitting middle-class pockets hard. But his doctor didn’t send him to the generic medicine store promoted by the government. “He prescribed only branded names of the drugs. Everybody’s out to make money,” Manish grumbled.
A new regulation, issued by the National Medical Commission (NMC), the apex regulator for medical education and profession, mandating physicians to prescribe only generic medicines, has been put on hold. But, if implemented, the concerns of leaving the choice of the brand to chemists and patient safety remain. The NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023 states that every registered medical practitioner “should prescribe drugs using generic names”. This means that the doctor has to write paracetamol as opposed to the brand name, Crocin or Dolo.
It further mandates that the prescribed drugs should be “rational”, and that the doctor should avoid giving unnecessary medication and fixed-dose combination tablets randomly. The penalty for disobeying could be suspension of licence for 30 days. Like many public health-related laws and regulations in India, the new directives have divided all the parties—not just the doctors and healthcare activists, but also experts who work for drug safety, chemists and the USD 50-billion pharmaceutical industry, which has 3,000 drug manufacturers and 10,500 manufacturing units and is expected to reach USD 130 billion by 2030. The new regulation, however, which comes after news reports exposed pharma companies offering unethical incentives to doctors to push their products, lacks clarity on what works best for the most important stakeholder in the equation: the patient.
Deterrent for Doctors
The NMC rules depart from the mildly worded Code of Medical Ethics Regulations, 2002, under the erstwhile Indian Medical Council Act, 1956, in which it said every physician “should, as far as possible”, prescribe drugs with generic names. While the earlier regulation was more like a guideline, the current avatar attracts a penalty for the first time. “Under the MCI code, the mandate for generic prescription was not enforced since there were no penalties. But now the NMC has introduced licence suspension if the rule is broken,” says Malini Aisola of All India Drug Action Network (AIDAN), which works for accessibility for all medicines in India. As per the directive, any aggrieved person can also complain about violation of the regulations against any doctor before the State Medical Council and Ethics and Medical Registration Board. These bodies can take suo moto action on gross misconduct.
There is, however, some leeway in the guidelines. Priyam Lizmary Cherian, a public health lawyer, says the word “should”, as defined in the NMC regulation, arguably indicates a lower level of obligation where there could be room for individual judgment. Also, in the case of drugs with a “narrow therapeutic index”, biosimilars, and other exceptional cases, the rule can be relaxed. Narrow therapeutic index drugs are medicines in which small differences in dosage or blood concentration could be life-threatening or cause an adverse reaction. Biosimilars are similar to biological products such as vaccines. But doctors are protected by loopholes in the rule. “This regulation can create some fear among them, but if the practitioner claims he prescribed a branded drug in an exceptional life-and-death situation, his explanation can be considered. It will depend on how the State Medical Council and Ethics and Medical Registration Board interpret the regulation. Moreover, the aggrieved parties are not allowed to hire lawyers, making the issue a non-legal dispute. It is possible they will end up seeking justice at consumer forums,” she adds.
Putting the cart before the wheel
According to the Economic Survey 2023, India ranks third in the global production of pharma products by volume and 14th by value. It is also the largest global provider of generic medicines, contributing 20 percent of the global supply it produces more than 60,000 generic drugs across 60 therapeutic categories. The domestic market currently consists of three kinds of drugs: patented, branded generics, and ‘generic generic’. In the case of patented drugs, the manufacturer has the exclusive right to make, use or sell them for a defined duration, and the medicines are often prohibitively expensive. Usually, only one manufacturer has a monopoly. All generic drugs are off-patents. But the ones that are branded and marketed extensively are labelled branded generics (Crocin, Dolo, etc.). ‘Generic generic’ drugs do not have a brand name and often cost a fraction of the other two. For example, large corporations such as Cipla sell low-cost generics, which they do not market alongside their branded products. Some doctors refer to them as branded generics.
“The new regulation is like putting the cart before the wheel. It is not up to the government to decide what kind of drugs our citizens will consume,” says Kerala-based physician Dr RV Asokan, who is also the National President-Elect of the Indian Medical Association (IMA). The medical body has issued a statement saying the NMC step is “ill-advised” and can directly impact patients’ “care and safety”. The IMA is a voluntary body of physicians in India, which has over 3.5 lakh doctors as members with the objective to ‘promote and advance medical and allied sciences in all their different branches and to promote the improvement of public health and medical education in India’.
Citing previous government reports, which admit to the presence of spurious and substandard drugs in the market, Dr Asokan says the real mechanism to ensure quality drugs is to trust the doctor. “If I write out a generic drug, the patient will go to the market where hundreds of brands are available for the same medicine. A pharmacy is not a professional establishment, and the chemist will dispense what he thinks will make him the most profit. What is the point of removing the doctor from the equation and giving power to a medical shop?” he asks. But can doctors be sure about the quality of the drugs they are prescribing? “It’s a matter of clinical judgement. If the doctor needs more information, they can go to the company’s website and check for various parameters,” he adds.
Pharmacists disagree, however. Jagannath Shinde, the president of the All India Organisation of Chemists and Druggists, which represents 12.40 lakh chemists from the country, says, “In countries such as Australia, doctors usually write a prescription and the pharmacist is the one who fills it. We know more about pharmacy than the doctors.” He’s quick to add a caveat though: “Principally, I think it’s best if the doctor decides what medicine should be prescribed.” A few chemists from Delhi and Bengaluru, too, say they are more comfortable with filling doctors’ prescriptions rather than doing the decision-making. Atul Kumar, who runs a chemist store in the Domlur area of Bengaluru, says, “This regulation is a premature move.
Our customers are finicky and believe in their doctors.” Also, in a country like India, not all chemist shops are run by qualified pharmacists as mandated by law, especially in rural areas. Therefore, the onus of the implementation of the rule depends on the state. Dr Viranchi Shah, National President of the Indian Drug Manufacturers’ Association, says the MCI regulation worked well in building an efficient healthcare ecosystem. “We benchmarked the availability and affordability of quality medicines, which is the national goal.”
Safety concerns
The Indian pharmaceutical industry is under the spotlight after the recent scandals, which involved the deaths of children in Gambia in 2022 and Uzbekistan this year from consuming cough syrup adulterated with ethylene glycol. Closer home, in 2020, nine children in Jammu died after taking cough syrup, which was found to be adulterated with the same substance. In the case of Gambia, the Indian government gave a clean chit to the Delhi-based manufacturer, Maiden Pharmaceuticals, explaining that the government laboratory found that the syrups were tested in compliance with regulations.
Uzbekistan’s state prosecutors alleged that the distributors of the Noida-based company, Marion Biotech, offered them a bribe of $33,000 to skip mandatory testing and issue the license. Testing is a massively time- and money-consuming exercise that every drug is put through before it hits the pharmacy shelves.
In April, the Centre for Disease Control linked an artificial tear drops product made in India with an outbreak of extensively drug-resistant eye infections that caused vision loss and even death in some cases.
Dinesh Thakur, a public health activist who campaigns to improve the quality of affordable medicines, points out an endemic problem with the Indian pharmaceutical industry. “There is zero transparency in the way the market is regulated. Here, the companies are known to shred documents, not follow SOPs, and lie to regulators,” accuses Thakur, who is the co-author of The Truth Pill: The Myth of Drug Regulation in India. He adds that the standards used in manufacturing drugs in India are weaker than in the US and the European Union.
An investigation by Bloomberg reported that in 2019, US-FDA told the US Congress that India had the lowest percentage of acceptable inspection outcomes—83 per cent—at drug manufacturing facilities across the countries it policed. A 2015 study, Current Scenario of Spurious and Substandard Medicines in India: A Systematic Review, found that in 2000, around 35 per cent of global sales of counterfeit medicines came from India. Spurious, substandard and misbranded drugs are a national concern too. In July this year, MoS for Health, Bharati Pravin Pawar, revealed in the Rajya Sabha the results of drug sampling conducted between April 2021 and March 2022. Over 2,500 of the 88,844 samples tested
were ‘not of standard quality’ and another 379 drugs were identified as fake.
Chinu Srinivasan, co-founder of LOCOST, a generic drug manufacturing company in Vadodara, Gujarat, says drug regulators need to do more to plug the holes, and that there is a huge shortfall of drug inspectors to conduct checks at manufacturing units. The 59th Parliamentary report of 2012 showed that for more than six lakh retail outlets and 10,500 manufacturing units in the country at the time, 3,200 drug inspectors were required, but there were only 1,349, of which only 846 inspectors were in place. “Over the years, there have been so many instances of adulterated drugs being discovered in the market. The prosecution of cases is not followed to its logical end. The state regulators are often aware about which manufacturers are unscrupulous, but neglect to do their duty,” says Srinivasan, who is also associated with AIDAN. Can generic medicines trump their branded counterparts? “If made by an ethical, conscientious company in India, which meets all legal requirements, generic drugs will be as good as any branded ones,” he says.
Bitter pill to swallow
India is expected to account for 13 per cent of the global pharma market, according to a report by Asian Lite, which calls this growth an outcome of a series of ‘sound legislation and economic environment, timely actions, and to a greater extent, the motive of the welfare of the masses’. Despite the advancements, when it comes to the quality and safety of drugs, the regulatory structures are so inadequate that many prefer to buy the branded drugs alone. “In a way, we are in a colonial trap. We trust big companies, believing that smaller players with required qualifications cannot make good quality medicine,” says Srinivasan. This is a common conundrum, which is aggravated by the fact that neither doctors nor chemists possess special skills to judge which drug is more effective.
“The pharma business is driven by the strong marketing and promotion of drugs that involve doctors in a big way. They may often rely on the reputation of a big company or, worse, favour the one that is giving them incentives. While the previous MCI code prohibited offering inducements to doctors, it had gaping loopholes and was not enforced, which rendered it ineffective. On the other hand, the companies and their representatives are never regulated,” Aisola says, referring to the regular visits made by medical representatives to clinics, where doctors often accept gifts, free holidays, hospitality, cash or monetary grants, consultancy fees and honorariums, and access to entertainment or recreation.
Dr SP Kalantri, director of Mahatma Gandhi Institute of Medical Sciences, Sevagram in the Wardha district of Maharashtra, agrees that some doctors are driven by market forces, but not all can be painted with the same brush. “Some multinational companies have a reputation to guard compared to relatively obscure companies. If the drug regulator was competent, there would be no issue, but right now there is no way to know which drug is spurious, whether bioavailability or bioequivalence is tested or not. The doctor has to work in uncertainty,” he says. Take the 2023 paper on a drug named Itraconazole used to treat Chronic Pulmonary Aspergillosis, a lung infection.
The doctors from the Postgraduate Institute of Medical Education and Research, Chandigarh, tested patients with both generic and innovator brands (companies holding the original patent for the drug which has now lapsed). They found that a higher percentage of patients responded better to the innovator’s brand. But such studies are too few and far between. “The government should fund longitudinal studies that focus on the effectiveness of drugs used to treat chronic diseases such as blood pressure or diabetes,” says Thakur. In many cases, the impression of the safety of the drug is more often perception and comfort with certain brands than scientific. But the onus of selecting medicines is a burden doctors have to bear. “There is no accountability when it comes to chemists and pharmacies.
A doctor, on the other hand, is answerable to the patient and has a reputation to maintain. The relationship between the doctor and patient is important for therapy,” Dr Kalantri says.
What ails the system?
Vipin Kumar runs a Janaushadhi store in Mehrauli, Delhi. His shelves are predominantly white and blue, without the colourful branding. He says except for government hospital doctors, all others prescribe branded names. “If a branded drug costs Rs 5,000, it is priced at Rs 2,000 here. The household can reduce its medical bills by Rs 10,000. There is no problem with their quality either,” he claims. Janaushadhi stores, too, have been in the eye of the storm with some drugs having been recalled owing to quality issues. While most people are used to walking around the block to the chemist to buy medicines, some patients travel at least 3-4 km to reach Kumar’s store.
“Look at this metformin strip. It is Rs 186 near my house, but here it is Rs 100. If I come here regularly to buy my medicines, I save about Rs 2,000 per month,” says 34-year-old Sushil Sharma, who travels the distance to buy generic medicines. A 2018 study in Karnataka showed that people have poor perceptions about generic medicines. An objective testing, however, done on some of the drugs in the lab, showed that both branded and generic drugs complied with legal standards.
Singh, who runs a regular chemist store next to the Mehrauli Janaushadhi store, recalls customers complaining that the “cheap” medicines don’t work. “The customer does not like to take any brand of medicine other than the one advised by the doctor,” says Singh, adding that if the NMC rule is implemented, chemists like him are likely to shift to generic medicines because their margin of profit will be higher. A generic drugs manufacturer, who spoke off the record, now laments that all the marketing money and time they spent on promoting their branded generics will go for naught.
A regional sales representative of a local pharma company visiting Balbir Singh’s shop says gloomily, “If this regulation is implemented, the entire marketing department will be sacked. My job will be redundant.” When the cost of medicine decreases, compliance increases. Dr Kalantri says his hospital managed to bring down the cost by negotiating a better price from the bigger companies, which sell both branded and unbranded drugs. “In our hospital store, we sell low-cost branded generics. For patients with heart disease, diabetes and lipid problems, they need about seven drugs. We ensure that the cost does not exceed Rs 150 per month,” he says.
Some public health experts rue the dangerous fact that the NMC regulation does not have any control over the chemists. “Special discounts are given to dealers to sell particular kinds of drugs. The regulator must ensure the quality of the drug and prohibit chemists from accepting gifts from pharmacy companies,” says Dr. Yogesh Jain, a community health doctor who practices in rural Chhattisgarh. He sees it as the first step towards nationalisation of the pharma industry. “If we can regulate banking, why not the drug industry?” he asks.
The only indisputable fact is that the country needs good quality, affordable drugs. Farsin Ahmed knows this too well. The 23-year-old postgraduate student has been suffering from hair loss for a couple of years. As a student with limited income, he is unable to keep paying for the branded lotion prescribed by his doctor, which costs about Rs 600-800 per month. He went for the first time to the Janaushadhi store to buy the generic version, which is priced at about Rs 160. Does he trust the medicine? “I have nothing to lose really. I have already lost a lot of hair,” he says. Unlike Ahmed, the millions of patients who visit doctors and chemists have a lot to lose. In some cases, even their lives.
What is a generic medicine?
A generic name is the international nonproprietary name (INN), which identifies the pharmaceutical substances of active ingredients. The salt name is unique and globally recognised; nobody owns the name. For example, if aspirin is the INN, the brand name would be Disprin.
Generic drugs are commonly understood as the opposite of patented. The latter are those that have a registered patent, allowing the manufacturer the exclusive right to make, use or sell the drug for a defined period. Under Indian laws, that period is 20 years. Generic drugs are off-patent.
There is another classification in the market—generics that are sold under brand names, for example, Crocin or Dolo. This is an off-patent drug, but has, through extensive marketing, gained a reputation in the market. These drugs may be priced less than the branded patent version, but are costlier than the bulk-manufactured generic version. There is less regulatory control over the prices of these ‘branded’ generic drugs. Often large corporations such as Cipla sell low-cost generics that they do not market along with their branded ones. Some doctors refer to these as low-cost branded generics.
The National Medical Practitioner (Professional Conduct) Regulations, 2023
Regulation
Household out-of-pocket expenditure on health
The Indian pharmaceutical industry is a USD 50 billion market It is ranked 3rd worldwide in the production of pharma products by volume and 14th by value. The sector occupies a 20 per cent share in global supply by volume and makes 60 per cent of the world’s vaccines. Indian companies export medicines worth USD 25.4 billion. 96 per cent of the domestic market is generic (off-patent drugs). Most of it consists of branded generics, with only 3-4 per cent being sold by their generic names
“The new regulation puts the cart before the wheel. It is not up to the government to decide the kind of drugs citizens will consume. It is my choice, and I will pick the one with credibility.”- Dr RV Asokan National president-elect, Indian Medical Association
"While the previous MCI code prohibited inducement to doctors, it had gaping loopholes and was not enforced. On the other hand, the companies and their representatives have never been regulated.”- Malini Aisola All India Drug Action Network
“There is zero transparency in the way the market is regulated. Here, the companies are known to shred documents, not follow standard operating procedures, and lie to regulators.”- Dinesh Thakur Public health activist
“The word ‘should’ as defined in the NMC regulation regarding the prescription of generic medicines arguably indicates a lower level of obligation where there could be room for individual judgment.”- Priyam Lizmary Cherian Public health lawyer
“In countries such as Australia, doctors usually write a prescription and the pharmacist fills it. We know more about pharmacy than the doctors.”- Jagannath Shinde President, All India Organisation of Chemists and Druggists
“The MCI regulation worked well in building an efficient healthcare ecosystem. We benchmarked the availability and affordability of quality medicines, which is the national goal.”- Dr Viranchi Shah National President, Indian Drug Manufacturers’ Association
“In a way, we are in a colonial trap. We only trust big companies, believing regular people with the required qualifications cannot make good quality medicine.”- Chinu Srinivasan Co-founder, LOCOST, a generic drug manufacturing company
“There is no accountability when it comes to chemists and pharmacies. A doctor, on the other hand, is answerable to the patient.”- Dr SP Kalantri Director, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra
“The move could be the first step towards nationalisation of the pharmaceutical industry. If we can do it for banking, why not for the drug industry?”- Dr Yogesh Jain Community health doctor, rural Chhattisgarh