Cough syrup tragedies are a wake-up call

In a fresh blow to the Indian pharmaceutical industry, the World Health Organisation (WHO) has warned against the use of two Indian cough syrups for children that have been linked to at least 18 deaths in Uzbekistan in December last year. The WHO said the products manufactured by Marion Biotech, a Noida-based pharmaceutical firm, were substandard and that the company had failed to provide guarantees about their safety. The production licence of Marion Biotech was cancelled earlier this week.

On October 5, 2022, the WHO had sounded a global alert, linking the death of 66 children in the Gambia with the consumption of cough syrups manufactured by a pharmaceutical company based in Haryana. The WHO had stated that the laboratory analysis of samples of the products confirmed that they contained high amounts of ethylene glycol (EG) and diethylene glycol (DEG). Both these substances are toxic to humans and can cause acute kidney injury, leading to death.

Soon thereafter, the Central Drugs Standard Control Organisation (CDSCO) had set up a committee of experts and launched a detailed investigation in collaboration with the state drugs controller of Haryana. India’s drug regulator subsequently stated that the samples of Indian-made cough syrups linked to the Gambian deaths were tested in a government laboratory and found to be complying with the specifications.

The problem of cough syrup contamination is neither new nor exclusive to exported products. There are reports that during the past couple of years, children have died in J&K and Himachal Pradesh after having consumed EG/DEG-adulterated cough syrups.

India, which regards itself as the pharmacy of the world, has a $42-billion pharma industry and is the third largest drug producer in the world. During 2020-21, the country exported pharma products worth $24.6 billion. The top five places where India sends medicines are the USA, the UK, South Africa, Russia and Nigeria. About 40 per cent of the generic medicines sold in the US and a quarter of all medicines dispensed in the UK go from India.

The deaths in the Gambia and Uzbekistan offer us an opportunity to reassess the drug manufacturing system and regulatory environment in India. Such an exercise would be beneficial nationally as well as globally, given the burgeoning export market for Indian medicines and the tremendous growth potential.

In India, the CDSCO is the apex agency which approves new drugs/molecules, clinical trials leading to drug registration, quality control and coordination of activities with the states. Its counterparts in the states carry out inspection of facilities, issue licences to manufacturers and undertake periodic quality checks. The CDSCO has authorised the State Licensing Authority to issue permission for export of medicines. The Drugs and Cosmetics Act-1940 provides for punishment for not maintaining the quality of drugs.

The onus, therefore, to inspect the factories, check the quality and give export licence falls on the state-level drug regulatory agencies. Their capability and capacity to carry out their responsibilities vary widely. Poor training, an antiquated record-keeping system and staff shortage make it difficult for the inspectors to do their job properly. An analysis of the India’s pharma industry points to underfunding of the oversight bodies and lax interpretation of the rules.

Moreover, the Central organisation and state agencies often function almost independently. The presence of multiple regulatory authorities under different state governments impacts accountability.

What can be done to improve India’s drug regulatory system? A revision of the Drugs and Cosmetics Act is overdue. The Union Ministry of Health and Family Welfare had released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022, for public consultation in July last year. Once enacted, the draft Bill will replace the existing Act. The Bill brings hope of stricter regulation to ensure the quality of drugs.

The Government of India has launched several schemes to support the pharma industry. In 2022, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers unveiled the scheme, ‘Strengthening of Pharmaceutical Industry’. With a total financial outlay of Rs 500 crore, the scheme will extend support required to existing pharma clusters and MSMEs across the country to improve their productivity, quality and sustainability. The objective of the scheme is to strengthen the existing infrastructure facilities in order to make India a global leader in the pharma sector.

The scheme has three components/sub-schemes: Assistance to Pharmaceutical Industry for Common Facilities to strengthen the existing pharmaceutical clusters’ capacity; Pharmaceutical Technology Upgradation Assistance Scheme to facilitate micro, small and medium pharma enterprises of proven track record to meet national and international regulatory standards; and Pharmaceutical and Medical Devices Promotion and Development Scheme to facilitate growth and development of pharmaceutical and medical device sectors through study/survey reports, awareness programmes, creation of database and promotion of industry.

The Pradhan Mantri Bhartiya Janaushadhi Pariyojana was originally launched in 2008 as the Jan Aushadhi scheme. It aims to make quality and affordable generic medicines available to all. To achieve self-reliance and minimise import dependency, the Department of Pharmaceuticals initiated a production-linked incentive scheme to promote domestic manufacturing by introducing critical key starting material, bulk drug parks, etc. with a cumulative outlay of Rs 6,940 crore for a decade.

India has no option but to create a robust regulatory structure with a strong enforcement arm so that medicines for both domestic use and export are of high quality. It should take a serious look at the core issue of why batches of exported cough syrups have been found to have EG/DEG. Admittedly, mistakes can happen. But not taking corrective measures threatens to undermine the trust in the Indian pharma industry.

As the pharmaceutical industry looks to expand its business across the globe, the key to success is continuous investment in upgrading the manufacturing standards. India must retain its image of supplying high quality and reliable medicines to the world. It is not enough to be a volume leader; India must add value to volume leadership.