The growing threat of fake, substandard medicines

THERE have been several disturbing reports about the quality of some commonly used drugs. The Central Drugs Standard Control Organisation (CDSCO), in its monthly report for August, declared more than 50 drugs as 'not of standard quality' (NSQ). They include the commonly used paracetamol, vitamins and calcium supplements, available over the counter. Medicines that failed the quality check also include anti-ulcer drug pantoprazole, anti-diabetic drug glimepiride, hypertension medication telmisartan and some life-saving antibiotics. Another five drugs were declared spurious, adulterated or misbranded.

This raises safety concerns about the use of not only these drugs but also others.

The CDSCO releases a list of drugs in the category of NSQ every month from amongst the drugs that are randomly checked in the pharmacies. In February 2023, as many as 1,251 drugs were checked and 59 were found to be NSQ. In March 2023, 48 of the 1,497 drugs tested were NSQ.

Though it amounts to less than 0.05 per cent of all drugs tested, it is a serious matter for a country which claims to be the pharmacy to the world. India has the highest number of US-FDA-compliant plants outside of the USA and over 3,000 pharma companies, with a network of over 10,500 manufacturing facilities. The country is the largest manufacturer of generic drugs and vaccines in the world.

Drug manufacturing, distribution and sale in India are regulated by the Drugs and Cosmetics Act, 1940. The state drug regulatory bodies regulate the grant of licence, production, marketing and distribution of medicines while the central drug regulatory body is responsible for approving new drugs and clinical trials.

From time to time, the Indian pharma industry has come under a cloud. A couple of years ago, there was international uproar over deaths in Africa following the ingestion of a cough syrup made in India. A similar episode had been reported in Uzbekistan. There was an instance of five deaths at PGI-Chandigarh due to the use of a substandard anaesthetic agent, propofol. About 15 years ago, Ranbaxy, a leading pharmaceutical company, was found by the US FDA to have falsified data and test reports at its manufacturing plants in India.

As per the CDSCO report, some drugs were found to be spurious, with the manufacturers claiming that they had not made them at their facilities. This raises the question of whether they have been made by some other manufacturer and marketed under a renowned brand. This would amount to the drugs being fake.

One can imagine what would happen if intravenous drugs were made spuriously. They would cause instant reaction, shock and, even, death.

Drug-manufacturing in India is supposed to be well regulated, with each manufacturer required to have basic infrastructure, trained manpower and due licensing. However, getting a licence to start one’s own production is not a difficult task. This is evidenced by the mushrooming of drug-making units like a cottage industry in many states.

At the same time, we have a category comprising state-of-the-art units of major companies which comply with the US FDA norms. They conduct periodic inspections and verifications. The second category of units adheres to WHO standards, with periodic checks. The third category is the one which is certified to be following good manufacturing practices (GMP). There is a gradient of quality in these three types of manufacturing.

The quality of drugs in India is dependent upon the sanctity of the manufacturing processes followed by the company. Certain MNCs would rather destroy the whole batch of a questionable product than bring it to the market. That is not the case with some smaller companies. For them, profit-making supersedes patient safety. This is exemplified by third-party manufacturing by many companies.

The active pharmaceutical ingredient (API) in each drug has to meet the purity standards laid down. But since most APIs are imported and their cost depends upon the actual concentration of the compound, an element of cost-versus-quality exists. Then, the finished product has to meet the standards laid down in the Indian Pharmacopoeia, which include drug assay, dissolution and tests for particulate matter and pathogens etc. It is the job of drug inspectors to check the manufacturing processes at each facility periodically. They also collect samples of drugs for analysis and enforce legal standards.

One of the main problems with ensuring the quality of drugs manufactured in India is the permissiveness in licensing drug-manufacturing units. The government gives licences to 15-20 companies to make the same drug from the same APIs. Many larger companies outsource some of their products to third-party manufacturers. Then, there are ghost manufacturers where the licensee may not have a manufacturing unit and gets the drugs made from another unit. The end result is a compromise on quality.

To make matters worse, there are groups of chemists and doctors who set up their own units to make some fast-selling products. The recent directive of the government to prescribe generic medicines and the opening of Jan Aushadhi stores, which dispense cheaper generic medicines, has led to the mushrooming of small manufacturing units. This makes their regulation difficult.

The Indian pharmaceutical industry is hampered by outdated regulations, weak penalties and slow prosecution. Two years ago, the manufacturers of the substandard cough syrups were made to suspend manufacturing of only those drugs and allowed to continue with the rest of their activities. Earlier this year, the Drugs Controller General of India announced policy initiatives on three issues: recall guidelines, norms on good distribution practices and the use of similar brand names by pharma companies for their drugs. But the implementation of the remedial measures is tardy.

The monthly alert report of the CDSCO is a positive initiative of the government, but a lot more is required to be done. There is an urgent need to make the raw material or the APIs in India. Currently, a majority of them are imported. At the ground level, a larger trained and skilled workforce is needed. The government should spare funds for technology for analysis and testing. Drug-unit licensing and regulations to run them should be more stringent. At the same time, stiffer penalties are required for defaulters.

Nobody should be allowed to play with our lives.