Drug regulator’s ‘testing’ proposal can help India regain credibility

Drug regulator Central Drugs Standard Control Organisation (CDSCO) has proposed that government-run laboratories should test cough syrups before they are exported. It is being taken forward by the Union Health Ministry and Department of Pharmaceuticals, which are reportedly working on a robust mechanism for testing. There is no denying that this is a good move, and the sooner it is implemented, the better it would for the domestic pharmaceutical sector and for the countries where they are exported. The country’s image was tarnished in the global market when it was found last year that cough syrups made by some Indian companies allegedly led to dozens of deaths in The Gambia and Uzbekistan. The World Health Organization (WHO) had held Indian company Maiden Pharmaceuticals responsible for exporting a syrup to The Gambia containing lethal chemicals ethylene glycol (EG) and diethylene glycol (DEG), which, incidentally, are used as car-brake fluid. Marion Biotech had sent cough syrup to Uzbekistan, which also contained EG or DEG.

The two firms denied the charges, but the facts cannot support their claims. Media scrutiny showed that Maiden Pharmaceuticals was a serial offender, having flouted countless norms in the past with impunity. Many states had flagged its products as substandard. Marion Biotech’s licence was also suspended by the Pharmaceutical Export Promotion Council of India (Pharmexcil) as it failed to respond to its queries. Pharmexcil, a body set up by the Ministry of Commerce & Industry to promote drug exports, issues a registration-cum-membership certificate, which is a mandatory provision.

Evidently, there are some lacunae in ensuring the quality of medicines. Otherwise, the two pharma firms, especially Maiden, would not have been able to export contaminated syrups. Their unethical practices came to light seven months ago but the quality of pharma exports still remains an issue. Last month, the Centre for Disease Control and Prevention (CDC) flagged the likelihood of highly drug-resistant bacteria linked to eye drops made by Chennai-based Global Pharma Healthcare. Unlike in the case of Marion and Maiden, India supported Global Pharma Healthcare. Tamil Nadu’s drug regulator was also on the same page. In April, the WHO warned about another India-made, contaminated cough syrup being sold in Marshall Islands and Micronesia. All these reports have an ominous ring about them, for they cast a shadow on our pharmaceutical exports.

In the last few years, India has done well in selling medicines all over the world. Pharma exports rose from $16.79 billion in 2016-17 to $25.3 billion (Rs 208,231 crore) in 2022-23. It would indeed be tragic that the greed of some immoral businesspersons ends up hurting the prospects of a thriving sector.

This is not just about exports but also humanity. No one should be allowed to sell any pharmaceutical products that are so contaminated that they kill children or adults, irrespective of the country. All culprits, nay killers, should be dealt with an iron hand; the comeuppance must be swift and severe.

At the same time, however, the government, at various levels, and regulators should ensure that compliances don’t become cumbersome; the entire pharmaceutical sector should not suffer because of the depravity of a few black sheep. That will be the bigger challenge.