Don’t let drug manufacturing become a cottage industry

EARLIER this month, the National Medical Commission (NMC) notified the 2023 guidelines on the professional conduct of registered medical practitioners (RMPs). They include duties and responsibilities of the RMPs towards their patients, the public and their colleagues, besides advice regarding the Continuing Professional Development Programme to update their skills periodically, prohibiting soliciting of patients and guidance about the use of social media. The guidelines also stipulate that RMPs should prescribe only generic medicines and that failure to do so will attract punishment, including cancellation of the licence to practise medicine.

India is the largest provider of generic medicines, producing 20 per cent of the world’s supply, according to the government’s Economic Survey. Its $50-billion drug-manufacturing industry exports medicines to over 200 nations and makes 60 per cent of all vaccines. India has the highest number of US FDA-compliant drug manufacturing plants outside America, and India is labelled as the ‘pharmacy to the world’.

India spends less than 1.5 per cent of its GDP on health and around two-third of the medical cost is borne through out-of-pocket expenditure. Medical treatment remains a major cause of indebtedness in the country. Generic drugs are cheaper and there is no doubt that their use can bring down the cost of treatment. Thus, it is logical to ask whether doctors’ concerns over the clause on prescribing only generic medicines are justified.

The original drug molecule discovered or formulated by the innovator company is under a patent for a variable period of time and is sold as a patented or proprietary drug. It is costly because of the cost of research, clinical trials, post-marketing surveillance, etc. After the patent expires, different companies can manufacture the same drug, called ‘generic’, at a much cheaper cost since all the background expenditure is bypassed. Generic drugs can be ‘branded’ or ‘unbranded’. There are two interlinked issues involved in the prescription of any drug. Firstly, who decides what particular manufacturer’s drug is to be used, and secondly, the quality of the drug or its efficacy in curing the ailment.

The Indian Medical Association (IMA), a pan-India body of doctors, has opposed the clause stipulating mandatory use of generic drugs and demanded a foolproof system of quality assurance before switching over to the ‘generics only’ diktat. It has been pointed out that currently, the government allows a multitude of manufacturers to make and market the same drug. Resultantly, there are hundreds of brands of some commonly used drugs, some of them made by small units without assured quality. For example, there are close to 250 companies making pantoprazole and over 150 making amoxicillin. There must be many more which are not listed on Internet search engines. Less than 0.1 per cent of the drugs are tested for quality in the country. The association has said that if the NMC wants only generic drugs to be used, the government should simply give licences to pharma companies to manufacture drugs without brand names.

Currently, doctors prescribe a particular brand based upon their earlier experience with its efficacy. If only the generic drug is to be prescribed, it will be up to the chemist to dispense any one of the available generics. The responsibility will shift to the chemist, who may have reasons other than drug efficacy in mind — his profit margin, for example. The NMC also recommends that drugs should be purchased from Jan Aushadhi stores, which often do not stock many of the drugs. They are also not manufactured by any of the major drug companies.

Doctors raise doubts about the quality of generic medicines in India. A generic drug is supposed to fulfil quality check criteria, such as chemical equivalence, pharmacokinetics, bioavailability, solubility check, sterility, dissolution, purity and nature of excipients. Barring a few large companies, it is the smaller companies which make most generic drugs. Some of them are housed in flat-sized units. Starting from the quality of the raw agent to the actual manufacturing, sterility, quality control and testing, there is little standardisation in such units. At many places, the chemist himself gets into manufacturing commonly prescribed drugs. The fact that there is a huge variation in the prices of drugs of different manufacturers suggests that there is a lack of uniformity in manufacturing processes and standards.

A study titled ‘Indian Pharmacopoeia (IP) and how it impacts drug quality’ has pointed out by giving examples that drug manufacturing regulations of IP are frequently not in line with guidelines of the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use. The latter are considered a global benchmark for drug quality by the WHO. The IP also has different standards for proving chemical equivalence of generic drugs. Till 2017, generic drug manufacturers did not require bioequivalence studies. Thus, generic drugs available in the market with the same chemical molecule may not be the same.

To substantiate differences between generic drugs and innovator drugs, a recent study on chronic pulmonary aspergillosis, published in a reputed journal, Mycoses, compared generic brands of itraconazole, an anti-fungal agent, and its innovator molecule. It found that generic brands resulted in lower blood levels than those obtained by the innovator drug and this affected the outcome for the patients.

Another relevant but disturbing fact is that over 40 per cent of India’s total pharma imports are from China, and bulk drugs contribute 55-65 per cent of that. Amid the Covid pandemic, concerns were raised over this dependence. The government has introduced a production-linked incentive scheme for bulk drug projects to augment indigenous manufacturing.

There is a need to review the NMC guidelines on professional conduct, especially the clause on generic drugs. We must first take into consideration different viewpoints, assess the ground realities, regulate drug manufacturing in India, enforce good manufacturing practices and follow international norms. We need to discuss with medical bodies how best we can bring down the cost of drugs, while ensuring that quality is not compromised. Drug manufacturing is a serious matter and cannot be allowed to become a cottage industry.