Thursday evening saw the end of a half-month stand-off between the National Medical Commission (NMC), India’s regulatory body guiding medical professionals and the Indian Medical Association (IMA), a national voluntary organisation of physicians with over three lakh members.
The two had locked-horns over one of the provisions of the NMC’s notification on August 2 asking registered medical practitioners (RMP) to prescribe generic medicines only. The Health Ministry now seems to have bought time for both parties.
In its latest notification the NMC has suspended proposed regulations until further notifications. “The NMC Registered Medical Practitioner (Professional Conduct) regulations, 2023 are hereby held in abeyance with immediate effect,’’ noted the Commission.
Said Dr. Sharad Agarwal, national president, IMA: “This is a grand victory as the entire regulations have been held in abeyance. Medical community has prevailed for the good of the people.’’
The previous NMC’s Ethics and Medical Registration Board notification reads: “Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.’’
The IMA had demanded its withdrawal stating that it should not be enforced till there is assurance that the medicines meet quality standards.
Generic is much cheaper
Explaining its stand the Commission has said out-of-pocket spending on medication remains very high, and with generic medicines being 30 % to 80 % cheaper than branded drugs, prescribing generic medicines may bring down health care cost and improve access to quality care.
The IMA on the other hand raised objection to this provision in the notification and expressed their fear that the alleged poor quality of generic medicines available in India would adversely impact patient health and treatment. They even met with Union Health Minister Mansukh Mandaviya to put across their strong objection. The other arguments against the move include – leaving sales in the hands of chemists in an ecosystem where generic medicines available have wildly varying MRP and huge profit margins on same combination drugs manufactured by different companies. Unregulated proliferation of pharma companies making generic drugs and lack of choice for patients are also fears.
Even though doctors were required to prescribe generic drugs earlier, there are no penal provisions mentioned.
The suspended notification, however, said that case of violations, a doctor may be given a warning to be more careful about the regulations or instructed to attend a workshop or academic programme on ethics, personal and social relations, and/or professional training and on repeated violations, the doctor’s license to practice may be suspended for a particular period.
K. Senthil, State president, T.N. The Government Doctors Association said that this was not a new idea: a proposal to prescribe generic drugs has existed since 2016. “The only difference now is the quantum of punishment prescribed,” he said.
Pharmacists can choose
The problem, he explained, was that even if doctors did give generic drug prescriptions, pharmacists/chemists were under no such obligation and could give branded drugs to patients. “Also, prescribing combination drugs is not possible through generics,” he said.
On quality of drugs, he pointed to the dismal shortage of manpower in most States in the Drug Controller’s offices, and asked how it was possible to ensure good quality drugs in such a situation. Drugs available in India fall under the following categories – branded under patent drugs, branded generic (a branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies’ brand names. These drugs may be less costly than the branded patent version but costlier than the bulk manufactured generic version of the drug) and lastly generic drugs. Generic drugs are defined as a “drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use”.
There is less regulatory control over the prices of these “branded” generic drugs and this is also what has the doctors worried and they warn that any change in drug — especially for patients with chronic illnesses and critical care — may mean patients do not get the full benefit of a particular drug. There is no concrete evidence to show that generic drugs are equal to branded drugs, with respect to bioavailability, potency, efficacy, and impurity content.
There can be complications and some of the ailments and diseases can go out of control, doctors argued.
Quality is an issue
Pointing out that the bioavailability of a generic drug molecule is not assured by quality control or clinical trials, C.N. Manjunath, director of the state-run Sri Jayadeva Institute of Cardiovascular Sciences and Research, said the very fact that the same company that is manufacturing a branded drug also manufactures a generic drug means that there is a shift in quality.
He said one should not compromise on the quality of drugs, particularly in the critical care sector, including cardiac emergencies. Sundar Sankaran, who formerly headed the Indian Society of Nephrology (Southern Chapter) said maintaining stable drug levels in transplant recipients is vital. “Branded drugs and non-branded generic drugs may have variations in their formulation and potency which can potentially affect drug levels and outcomes for transplant patients. Lifesaving drugs like Tacrolimus and cyclosporine, which have a narrow therapeutic window, require careful monitoring and consistency in brand usage. Swapping between different generic brands could lead to variations in drug levels, putting the transplanted kidney at risk,” said the doctor, who is also the Director of Aster Institute of Renal Transplantation in Bengaluru.
Rajeev Jayadevan, member, Public Health Advisory Panel, Kerala State IMA, adds that the primary aim of the doctor is to ensure the complete recovery and well-being of the patient. Doctors’ prescribing patterns are established through years of practice and patient feedback. This is a relationship no pharmacy or medical shop can have with patients. ``When only a generic name is written on the prescription, even if a better quality version is available, the pharmacy salesperson will be encouraged to dispense those products with the highest profit margin. The quality control, storage, distribution and dispensation of drugs is not yet uniform in the country which is the main area of concern for doctors. If this is worked out — generic medicines will work well in India,’’ he said.
Rules for prescribing
NMC had in its notification also listed out the manner in which prescriptions have to be made and stated :”Prescribe drugs with generic, non-proprietary, pharmacological names only but in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed.
“Prescribe drugs rationally and optimally, both overprescribing and under prescribing are to be avoided keeping in mind possible drug interactions and fixed-dose combinations are to be used judiciously. Besides this only approved and rational fixed-dose combinations are to be prescribed,’’ NMC has noted.
It also advised hospitals and local pharmacies to stock generic drugs, prescribe only those generic medicines that are available in the market and accessible to the patient, avoid prescribing “branded” generic drugs and encourage patients to purchase drugs from Jan Aushadhi Kendras and other generic pharmacy outlets.
In the recently concluded G-20 health summit the Health Ministry maintained that for India -- healthcare is not just a sector, but a mission and that the country is currently supplying around 60% of the world’s vaccine needs and 20-22% of generic exports. Its $50 billion drug-manufacturing industry exports medicines to over 200 nations, as per some reports.
Committed to affordability
“The country is dedicated to providing affordable, high-quality drugs and contributing to global accessibility,’’ Union Health Minister Mansukh Mandaviya said while speaking alongside Ernst Kuipers, Health Minister of the Netherlands. He said medicines manufactured in India saves lives in Netherlands, in Europe and across the world.
Budi Gunadi Sadikin, Indonesian Health Minister, added that India’s Jan Aushadhi Kendra model is the best in the world in terms of providing quality, accessibility and affordability of medicines to the people.
Also just last month the Health Ministry directed regulatory authorities to conduct risk-based inspections and audits of manufacturing plants adding that Schedule M shall be made compulsory for the Micro, Small and Medium Enterprises (MSME) pharma sector in a phased manner. The move is aimed at helping in quality assurance and reduce compliance burden. Schedule M of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ that should be followed by pharmaceutical manufacturing units in India.
Meanwhile, individual doctors and healthcare activists have expressed their views on the stand-off between NMC and IMA. In a social media post S.P. Kalantri, director professor of MGIMS and Medical Superintendent of Kasturba Hospital said: ``The NMC’s bid to cut links between medical professionals and the pharma industry is sending shockwaves through India’s healthcare. But is this strict approach the solution? Bioequivalence testing is important because it shows that a generic drug works the same way as the original one tested in trials. Hence, should every drug—be it generic or branded—go through this before hitting the market? Is the NMC’s proposal too ambitious? Is it possible to untangle deep-rooted ties between doctors and the drug world?
Gopal Dabade, president of Drug Action Forum, Karnataka, said: “we welcome the NMC notification. Use of generic drugs will make healthcare affordable and cut out of pocket expenses for patients.’’ Disputing claims by the medical fraternity that switching to generic drugs may harm the patients, he said there was no scientific evidence to prove this.
(With inputs from Afshan Yasmeen in Bengaluru, Zubeda Hamid in Chennai and C. Maya in Tiruvananthapuram)
Bindu.p@thehindu.co.in
