The high cost of cheap drugs The centre has withdrawn its directive making the prescription of generic drugs mandatory—but only after raising the hackles of the medical community Listen to Story Live TV Share ADVERTISEMENT Illustration by Nilanjan Das Sonali Acharjee Sonali Acharjee ISSUE DATE: Sep 11, 2023 | UPDATED: Sep 1, 2023 20:15 IST For now, a medical row has been put to rest. The National Medical Commission (NMC), the regulatory body guiding medical professionals, has put on hold its order requiring doctors to exclusively prescribe non-branded generic medicines to patients. The NMC’s about-turn followed a meeting on August 21 at which representatives of the Indian Medical Association (IMA) spoke to the Union health minister Mansukh Mandaviya and expressed their apprehension about the quality of unbranded generics. This brought to an end a heated and nearly month-long debate between doctors and the government. However, the very possibility of such a directive coming into force has left many doctors shaken. Generic medicines are drugs that are not under patent, which means manufacturers other than the ones that came up with the medicine are able to produce it. According to NMC guidelines, a generic drug is one that is the same as a branded one in dosage form, strength, route of administration, quality and performance characteristics and intended use. There are two types of generic drugs—branded and non-branded. Branded generics are cheaper than patented medicine but more expensive than non-branded generic medicine. For example, Crocin and Dolo 650 are branded generic medicines for pain and fever. Paracetamol is the non-branded generic medicine for the same, and any company can make it. ADVERTISEMENT The August 2 fiat to determinedly push unbranded generic medicines wasn’t an isolated move. In May 2023, there were talks of passing a generic drug mandate for private hospitals as well. The rationale behind the NMC guideline was to reduce healthcare costs. Currently, the World Health Organization estimates, nearly 55 million Indians are pushed into poverty annually due to out-of-pocket expenditure on healthcare, especially for medicines. By promoting generic medicines—which are often 30 per cent to 80 per cent cheaper than their branded equivalents—the NMC hopes to reduce the cost of treatment in the country. The now-withdrawn NMC guideline also asked doctors to encourage patients to purchase medicines from government-run Jan Aushadhi Kendras and other generic pharmacy outlets. India is the world’s largest producer and exporter of generic drugs, with med­­icines worth over ã17 billion (Rs 1.76 lakh crore) exported last year. Not trusted by doctors Non-branded generic drugs are yet to win the confidence of doctors. Most say that the effectiveness and reliability of such medicines are hard to ascertain due to a lack of batch testing and the prevalence of haphazard approval pro­cedures. “There are thousands of small firms who manufacture the same salt as a branded medicine but these com­pletely lack infrastructure and tec­­hnical knowhow for quality control and testing. If every single batch of an unbranded generic was tested, the way branded ones are, then that instils faith,” says IMA president Dr Sharad Kumar. According to data from the Union ministry of chemicals and fertilisers, India produces over 60,000 gen­eric drugs across 60 therapeutic categories, manufactured by 3,000 firms in over 10,500 units. However, there is no current data showing the number of small units producing generic medicine. But, according to T.V. Narayana, president of Indian Pharmaceutical Association, the rise of e-pharmacies has significantly inflated the figure. “There is tremendous potential for pharmaceutical manufacturing in India. And the demand for India-made generics is high. But as supply increases it is important to enforce regular quality and compliance checks regardless of company size,” he says. According to IMA estimates, less than 0.1 per cent of generic drugs in India are tested for quality. In 2018, the Central Drug Standard Control Organisation (CDSCO) estimated that nearly 4.5 per cent of all generic drugs circulated in the domestic market were substandard. Poor quality medicines from India have been making global headlines. In 2022, 65 child deaths were linked to contaminated cough syrup made in India by a company called Marion Biotech. In August, the WHO issued a global alert about an Indian-made cold syrup called Cold Out, which is sold in Iraq. “I would not prescribe unbranded medicine to my family. There are many of highly dubious quality and others that don’t even work. How can I be forced to do so for patients?” says a doctor from a leading government hospital in Delhi, who does not wish to be named. ADVERTISEMENT Doctors are also outraged at what they perceive is a shift in decision-making power from physicians to pharmacists. By simply writing the generic name on a prescription, they are allowing pharmacists to decide which company’s unbranded generic drug the patient should take. “Treatment is not as straightforward as that—we need to take into account side-effects, medical history, allergies etc. before prescribing a drug. How can the NMC decide that the best person to determine which medicine a patient should take is a chemist?” asks Dr Kumar. In the event that an unbranded medicine fails to have an effect, or worse, has serious side-effects, doctors are worried about their reputation as well as violence from affected patients and their family. “Violence against doctors is a serious issue. I have had experience of patients, spouses or children being aggressive,” says Dr Ashutosh Sen, a general physician from Kolkata. “If I face the liability of my prescription, then I must also be allowed to prescribe a drug of my choice. Suppose the chemist prescribes a medicine from a brand that is not good quality and anything happens to a patient...my head will be on the chopping block,” he adds. ADVERTISEMENT Proponents of generic drugs point to the alleged role of big pharma in pressuring doctors to prescribe branded medicines. “This has never been proven and if the public starts to regard doctors as money-makers alone, there will be severe consequences. As doctors, we are under oath to save lives and that is our only mandate,” says Dr Kumar. ADVERTISEMENT What should be done In the August 21 meeting with Manda­viya, one of the proposals was to reduce the prices of branded generic medicines. “Reduction of tax can help reduce prices of branded generics. There should be rules to ensure quality, distribution and chemist regulation. We feel that the approach should be more flexible, allowing the doctor’s judgem­ent to prevail,” says Dr Girish Mathur, president, Association of Physicians in India. Finally, the government has begun to take steps to improve the quality of med­ical manufacturing. Of India’s 10,500 medicine manufacturing units, around 8,500 are in the MSME category. Only 2,000 units in this category have WHO GMP (good manufacturing practice) certification. Quality control for these come under Schedule M of the Drugs Rules, 1945, which govern production units and their maintenance, personnel, control and safety testing, storage and transport of material, wri­tten procedures and tra­­ceability. Last month, drug regulators inspected 162 units and 14 public testing labs and found lapses such as lack of process and analytical validations, abse­nce of quality failure investigation and internal quality review, as well as faulty design of manufacturing and testing areas. Based on these, GMP recommendations in the current Schedule M have been revised to reflect globally-accepted standards. Pharma companies with an annual turnover of over Rs 250 crore will have to adopt GMP recommendations in the next six months. Units with a turnover under that have been given an additional six months to comply. The government is also trying to ensure quality control of around 1,800 unbranded generics sold at its 9,600 Jan Aushadhi stores. “We do third-party and anonymous testing for our batches and only source from WHO GMP-certified firms after inspecting their facilities,” says Jan Aushadhi CEO Ravi Dadhich. “The batches are tested for permissible impurities, hardness, dissolution levels and effectiveness.” The chain has only four warehouses that supply all its stores, thereby ensuring each store keeps approved medicine. “In the last nine years, we have saved Rs 20,000 crore for Indians, with Rs 7,000 crore saved last year alone,” says Dadhich. He insists Jan Aushadhi can supply quality medicine at the most affordable price (at times, almost 90 per cent less than branded generics) with virtually no risk of adulteration or tampering. Ultimately, say experts, the goal should be to make healthcare more affordable without compromising on quality of drugs. For this, reduction in taxation, more economical manufacturing infrastructure and stringent monitoring of all processes will yield better results than to compel doctors to relinquish crucial decision-making power and prescribe only a certain type of medicine. EDITED BY SUDHANVA AYURVEDA OVERSEAS PVT LTD.