Enforcement of drug regulations remains lax

Dinesh C Sharma

Science Commentator

THE World Health Organisation (WHO) issued a ‘medical product alert’ on August 7 regarding a batch of substandard and contaminated cough syrup sold in Iraq. The matter was reported to the WHO on July 10. The global health agency obtained a sample of the product for an analysis, which found that it contained an unacceptable quantity of two contaminants — diethylene glycol (DEG) and ethylene glycol.

This cough syrup was manufactured by a company based in Chennai and marketed by another in Mumbai. Both firms, according to the WHO, have not provided any guarantee of the safety and quality of the product. Declaring that the substandard batch of cough syrup was ‘unsafe’ for use among children, the WHO has warned that it may cause serious injury or death. Toxic effects of the two contaminants include abdominal pain, vomiting, diarrhoea, inability to urinate, headache and acute kidney injury which may lead to death.

This is not an isolated case of contaminated cough syrups manufactured in India. In the past year, several cases of such contamination and deaths caused due to substandard medicines produced in India have surfaced. Many children have died in the Gambia, Uzbekistan, Cameroon and other countries after consuming ‘made-in-India’ medicines. The WHO has been constantly warning and advising national regulatory and health authorities to immediately notify it if such products are discovered in their respective country. It has asked manufacturers of liquid dosage forms, especially syrups that use agents like propylene glycol and polyethylene glycol, to test for the presence of contaminants such as DEG before use in medicines.

The Indian Government, however, has been ambivalent on the issue. Since the Gambia episode — in which over 60 children died due to suspected kidney injury caused by toxic chemicals in India-made cough syrups — no worthwhile action has been taken to remedy the situation. The Health Ministry, the drug regulator and industry bodies continue to be in the denial mode. To address the problem, it is necessary for all of them to first accept that there is a problem. The authorities first denied any connection between the Gambia deaths and the cough syrups made in India. They even accused the WHO of not following procedures and not sharing technical reports. They then saw a conspiracy in such cases — a conspiracy to defame India in the export market and dent its image as the ‘pharmacy of the world’. As a result of such tacit support from the political leadership and the regulator, the industry continued to be callous, resulting in more incidents of contamination and more countries reporting to WHO, like the latest case of Iraq.

On paper, India has a fairly good system of drug regulation governed by the central drug regulator and state drug regulators. The system is responsible for regulating everything — from manufacturing to labelling, product recall and quality. The drug regulation mandates that all licensed manufacturers follow Good Manufacturing Practices (GMP) as laid down by the WHO. The guidelines are exhaustive, covering everything from siting to the plant, procurement of raw materials from verified vendors, hygiene and sanitation in plants, manufacturing processes, quality testing of products, record maintenance, storage and transportation of finished products, procedures for product recalls, packaging and so on. Besides, there is a system to send inspectors to check if all things mandated in GMP are being adhered to.

In practice, however, drug regulation is pathetic. Even the most basic requirements of GMP and quality assurance are not being followed. For instance, the guidelines mention that all raw materials procured should be checked to ensure that the consignment corresponds to the order placed, and is approved by the quality control department for use. Such provisions are to prevent mix-up, mislabelling, etc, for similar-looking chemicals in the manufacturing process. If this procedure had been followed, Indian cough syrups would not have led to so many deaths in far-off countries. Both implementation and compliance are lax. A bulk of smaller and medium-scale medicine manufacturers can’t afford to invest in proper quality control testing facilities and personnel. However, they continue to be in the business and even exports because drug inspectors who are supposed to oversee compliance and enforce the law are not doing their job.

Instead of warning the industry to comply with the law and properly implement GMP, Minister for Health and Family Welfare Mansukh Mandaviya is offering more incentives to boost production and exports in the name of self-reliance and ‘Make in India’ programme. A total of Rs 15,000 crore would flow to the pharmaceutical sector under the Production-Linked Incentive (PLI) scheme of the government over the next five years. The first tranche of Rs 166 crore was released to the industry earlier this year. The government has not disclosed whether all recipients of the PLI scheme are GMP-compliant. In July, the minister launched incentive schemes worth Rs 500 crore for the sector. For the implementation of GMP, which has been mandatory since 2005, Mandaviya has given another incentive to the industry — one more year to implement it. On top of it, the Jan Vishwas (Amendment of Provisions) Bill, 2023, passed recently by Parliament, eases provisions relating to penalties for spurious drug manufacturing.

In public interest, the government must spell out the corrective measures it has taken since the Gambia episode. A four-member committee of experts was set up in October 2022 to investigate the matter. Its report was never made public, nor was any follow-up action announced. Forget any structural change, not a single head has rolled for the lapses that led to the tragic incident. There is every danger that products similar to the ones that have killed children in other countries are being sold in the domestic markets as well. Sweeping the problem under the carpet is not in the interest of Indian consumers. Let’s act.

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