Centre should act tough on bogus drug manufacturers

The drug regulator's drive to cancel licences of 18 companies for manufacturing spurious drugs should have been launched long ago. Reportedly, the action against these companies was taken after surveys were carried out by the Drugs Controller General of India on 76 companies spread across 20 states and union territories. This is apparently the first phase in the drive to weed out fraudulent drug manufacturers. Sadly, it has come too late to save the lives of children who died in several countries after being ingested medicines exported by Indian pharma companies.

Although belated, the crackdown is a welcome measure despite the fact that it was taken only after the reputation of Indian drugs was smeared abroad over a period of several months.

The first case involving paediatric syrups made by Maiden Biotech in Sonepat was reported to have caused the deaths of 70 children in Gambia. Shortly afterwards, syrups sourced from Noida-based Marion Biotech were held responsible for the death of 17 children in Uzbekistan. Though India protested that its companies were not responsible for these events, inspections later found that products made by Marion Biotech were not up to the required standard while samples from the other company passed muster.

The World Health Organisation, however, had issued a medical product alert about contaminated medicines from the Sonepat-based firm. India's drug controller is reported to have written to the WHO last December, presenting these findings and criticising the agency for affecting the country's pharma supply chain. He would have instead been well advised to take immediate measures to close down the fake drug units. A third case involving adverse reactions in the U.S. to eye drops made by a Tamil Nadu-based company was reported in February. This included not just eye loss but one death from the 55 cases that were reported. The company recalled all the eye drops but the damage had been done.

Though it had been mentioned last December that a committee would be set up to probe the issue, it has taken another three months for this crackdown to manufacturers of spurious drugs. The extent of the malaise can be judged from the fact that 203 notorious companies have been identified on the basis of random sampling.

In this context, one cannot shy away from the fact that the existence of a widespread network of fake drugs manufacturing units is an open secret in this country. Media has reported on this issue multiple times. Possibly the regulator may have taken action whenever such reports surfaced. But there has been no long term concerted action to weed out the frauds completely. The urgent need to do so cannot be underlined enough given that such bogus drugs are a threat to the lives of millions of ordinary consumers.

Spurious medicines can be of two types – the first comprising of harmless material that is ineffective in the curative process. The second type, in which harmful components are added to the formulation, is much more dangerous. The latter can not only cause ill-health but lead to deaths. In the case of the cough syrups that allegedly caused deaths in other countries, the harmful elements were apparently diethylene glycol and ethylene glycol, which can be toxic if ingested.

The drug regulator is expected to investigate such issues, but it must be conceded that the agency has to police an extremely large segment of industry. The Indian pharma sector is the largest in the world currently with 3,000 companies and 10,500 manufacturing facilities. It is obviously difficult to monitor the entire sector. Therefore, given the importance of the industry both in economic and human terms, the government needs to augment the drug regulator's infrastructure so that it can monitor the quality of output.

As far as the role of pharmaceuticals in the economy is concerned, it is evident that the industry comprises a sizable segment. It is currently valued at $50 billion and is expected to reach $65 billion by 2030. Pharma exports also form a big chunk of the country's export basket. These are set to rise to $25 billion in 2022-23 compared to about $24 billion in the previous year. India is the largest provider of generic medicines in the world. It has a share of 20 per cent in the global supply volume and contributes 60 per cent of vaccines to the world. It ranks third in terms of volume and 14th in terms of value.

It is thus clear that any cases of fraudulent or poor quality drugs will affect India's reputation in international markets as a reliable supplier of high quality affordable pharmaceutical products. Whether catering to foreign or domestic markets, these must be shut down at the earliest. Any laxity on this score will affect the reputation of the wider pharma industry that is producing quality products and maintaining high standards.

Apart from this, it is a human issue. No one should have to undergo any harm from consuming medicines that are meant to cure them. This is a critical matter and manufacturers, who play with human life, should be dealt with as per the most stringent provisions of the law.