On 17 April 2017, Prime Minister Narendra Modi, during the inauguration of a hospital in Surat, had reportedly indicated that the Government would make legal arrangements to ensure doctors prescribe generic medicines.

Six years later, on August 9, the National Medical Commission (NMC) notified regulations related to the professional conduct of registered medical practitioners (RMPs), which among others makes it mandatory for doctors to prescribe generic drugs as the norm, instead of branded drugs.

Even though RMPs were required to prescribe drugs with generic names legibly and preferably in capital letters nearly 21 years ago under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 notified by the erstwhile Medical Council of India on 6 April 2002, compliance was poor possibly because there were no penalties for non-compliance. However, under the new NMC regulations, failure to follow the directives will invite penalties. 

Studies have shown that health care costs are the second most frequent reason for indebtedness. A major component of health care costs is medicines which is anything between 50 to 80 percent of the total cost of treatment. The cause for concern is that there are reported instances where patients seeking care in public health facilities have to buy medicines from retail shops and these medicines are very costly for a variety of reasons. So, the intent to promote generic medicines is laudable because such drugs are nearly 30 to 80 percent cheaper than branded drugs and as India produces over 60,000 generic drugs in different 60 therapeutic categories, it doesn’t warrant any imports.

The Indian law, that is the Drugs and Cosmetics Rules, does not identify the distinction between generic, branded generics and branded medicines. Simply put, branded medicines (marketed under the brand names of their manufacturers) are usually promoted through doctors. Generic medicines are marketed under their chemical/salt names. Branded-generics refers to branded products that are not promoted to doctors but marketed to retail chemists. All categories of medicines, whether imported or manufactured, need to comply with the standards under the aforesaid Rules. The quality of all medicines sold in the country is monitored by the central and state Licensing Authorities through a system of collection of random samples and testing.

Way back in 2008, during the UPA regime, the Department of Pharmaceuticals had launched the Jan Aushadhi Scheme (JAS) or Public Medicine Scheme in order to promote generic medicines at affordable prices through the Bureau of Pharma Sector Undertakings (BPSU) of India, a special wing of Department of Pharmaceuticals. There have been several ups and downs and learning as well in so far as promotion of generic medicines are concerned.

The Department-related Parliamentary Standing Committee on Health and Family Welfare examined the issues relating to availability of generic, generic-branded and branded medicines and their formulation and therapeutic efficacy and effectiveness. In its 45th report presented to the Rajya Sabha and also laid on the Table of the Lok Sabha on 4 August 2010 among others the Committee had noted that in two years since its launch, only 46 JAS were opened in the country. It suggested that proactive intervention by State Governments down to District levels would be required to help people to procure life saving medicines at affordable prices. 

The Committee found that in Rajasthan’s Chittorgarh, the local administration procured generic medicines through open tender and sold them through Government Cooperative Medical Stores. Notably, a sharp fall in the treatment costs was observed. For example, treating pneumonia, involving 7 days therapy, was Rs. 1136 using branded medicines. But the expenditure fell to just Rs. 139.51 when generic medicines were purchased from Government Cooperative stores. A saving of Rs. 6.05 crore in the treatment of 4.03 lakh patients in 6 months was estimated. Also, private chemist associations agreed to sell generic medicines at 50 percent discount on MRP. Similarly in Bihar, even though exclusive medical shops (selling generic medicines at less than 50 percent of MRP) were set up in every medical college, district hospital and primary health centre, the Government earned 45 percent revenue. 

Let’s fast forward. As on 30 June 2023, there are nearly 9500 JAS rechristened as Jan Aushadhi Kendras (JAK) which sell generic medicines under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJPY). As indicated by the Prime Minister in his Independence Day speech this year, the number of JAKs is to be increased to 25,000. For instance, under PMBJY, 10 tablets of Amlodipine, used to treat high blood pressure (hypertension), is said to cost Rs 4 against Rs 21 for branded medicine. 10 tablets of generic Losartan, used alone or in combination with other medications to treat high blood pressure etc. is sold for Rs 6 against Rs 33 for branded. 10 tablets of generic Atorvastatin, used together with a proper diet to lower cholesterol and triglyceride (fats) levels in the blood, is sold at Rs 7 while the branded one costs Rs 43. Similarly, 14 tablets of Atenolol, a beta blocker medication primarily used to treat high blood pressure, heart-associated chest pain, migraines etc. costs Rs 6 when compared to branded being sold for Rs 20. A strip having 10 tablets of generic Clopidogrel, which helps prevent blood clots, is sold at Rs 15 and the branded at Rs 51. So, the savings by way of generic medicines is to the tune of 70 to 84 percent when compared to the cost of branded medicines.

According to the new regulations, RMPs need to prescribe drugs with “generic”/“non-proprietary”/“pharmacological” names only. In the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed. Besides prescribing drugs rationally and optimally, both over-prescribing and under prescribing are to be avoided keeping in mind possible drug interactions. Apart from desisting from prescribing “branded” generic drugs, RMPs ought to encourage patients to purchase drugs from JAKs and other generic pharmacy outlets

On the flip side, according to an Indian Express report, many studies from PGI, Chandigarh published in international journals prove that even in lethal diseases like cancer, generic drugs are very effective. In transplant, in preventing rejection of a transplant, generic drugs are equally effective, and that too, at one-fifth of the right price.

While many State-run hospitals like the JJ Hospital, Mumbai, AIIMS Delhi, etc. have welcomed the move to prescribe generic medicines, on the other hand, the Indian Medical Association (IMA), the country’s apex body of medical professionals with a membership of around 4 lakh doctors spread across the country, seems to be in no mood to accept the new Regulations in respect of RMPs requiring to prescribe only generic medicines. 

Calling the present promotion of generic drugs by NMC as running trains without tracks, IMA has stated in its press note dated 14 August 2023 that such a measure is just shifting the choice from a medical practitioner who is primarily concerned, trained and responsible for the patients’ health than a chemist/person sitting in chemist shop, who is selling drugs. This naturally wouldn't be in the best interest of the patient. (We should refrain from just cost cutting irrespective of quality treatment). 

Patient care and safety are not negotiable. If doctors are not allowed to prescribe branded drugs, then why such drugs should be licensed at all, given that modern medicine drugs can be dispensed only on prescription of doctors of this system. With less than 0.1 percent of the drugs manufactured in India are tested for quality, prescribing generic drugs according to the IMA should be deferred till the Government can assure the quality of all the drugs released into the market. Demanding the deferring of the new Regulations for wider consultations, IMA has urged the Government to have ‘one drug, one quality, one price' system whereby all brands need to be either sold at the same price which should be controlled or banned and only generics allowed while ensuring highest quality of these drugs. 

The new Regulations require RMPs to write prescriptions which are legible, preferably in full capitals to avoid misinterpretation. As far as possible prescriptions should be typed and printed to avoid errors. A prescription is not just a piece of paper. It is the formal communication from a doctor to a  pharmacist  authorising him/her to dispense a specific prescription drug for a specific patient. But what if the pharmacist wrongly interprets the prescription or displays callousness while giving the medicines? The consequences can be simply mind boggling. 

A Consumer Court in Chandigarh fined a chemist Rs 50,000 plus Rs 10,000 towards litigation cost for giving wrong medicine to a patient. After consuming the medicine for two days the health of the patient started to deteriorate. He was rushed to the hospital where the doctors after seeing the medicine told the patient that the chemist had given him medicine of diabetes although he was a non-diabetic patient.

A 64-year-old man and his 54-year wife had to be hospitalised in Mumbai as the pharmacist gave them wrong medicines. The couple were suffering from depression for the past three years and the wife had gone to the chemist to buy antidepressants with the prescription. The pharmacist gave wrong medicines and when the woman questioned him, he claimed their components were the same. The man after taking medicines meant to treat rheumatoid arthritis and psoriasis every day for a fortnight developed patches on his body and complained of breathlessness accompanied by fever. The woman’s platelets had dropped significantly. Their son admitted both of them at the hospital and when doctors looked into the couple’s medical history, they were shocked. The man had to be admitted in ICU with life support as his condition deteriorated while the woman was also placed under observation. 

Our public health system faces several challenges. The country spends only 1.25 percent of its GDP on healthcare, more than 80 percent of the population do not have any significant health coverage, etc. But it is the doctor-patient relationship which ultimately counts. I am reminded of our 65-year-old family doctor who passed away recently. He made it a point to not only spend quality time with each patient but also took his own time to clearly write the prescription. He would then ask the patient to procure the medicines and show it to him. Only after he was satisfied that the medicines were correct, he would accept his consultation fee. Such small steps really go a long way in ensuring the patient gets the right medication.