Is India doing enough to clean up its pharma industry?

Following reports of scores of deaths linked to Indian-made cough medicines, the government in New Delhi has introduced mandatory sample testing for cough syrups destined for export from the beginning of June.

At least 18 children died in Samarkand after allegedly consuming the Doc-1 Max cough syrup prepared by Indian pharmaceutical company Marion Biotech. Cough syrups manufactured by the Indian drugmaker, Maiden Pharmaceuticals , have also been linked with the deaths of 66 children as well as acute kidney injuries in Gambia.

Contaminated cough syrups tarnish India's reputation

The decision came as a response to quality concerns raised abroad in India's pharmaceutical export markets. The government has listed a number of state-approved laboratories across the country where samples could be tested.

An additional layer of quality control has also been put in place for cough syrups due to the reports of contamination with glycol and ethylene glycol — toxic substances that can sometimes be fatal, especially for children.

While pharmaceutical experts and public health professionals have called the move an important step, they maintain that quality control for all drugs, and not just cough syrups, needs to be made a priority.

Official figures show that India's pharmaceutical industry is the third largest in the world in terms of volume and 14th largest in terms of value, with the sector contributing to around 1.72% of the country's GDP.

According to government data, the industry is worth approximately $50 billion (€46.44 billion) with more than half of that coming from exports. Around 20% of the global demand for generic drugs is met by India.

"The spate of issues related to cough syrups over the past year introduced uncertainty and caused damage to the reputation of the industry," Nakul Pasricha, president and CEO of India's PharmaSecure, told DW. "India has thousands of high-quality pharmaceutical manufacturers, but the lax and unethical practices of a few bad apples has the potential to cause immense damage to the reputation of Indian drug exports."

Pasricha works with leading pharmaceutical makers to track and verify their supply chains and ensure the authenticity of their drugs. He said the Health Ministry's move in March to cancel the licenses of 18 firms for quality violations, and the introduction of the testing requirement, would go a long way toward dispelling doubts while ensuring the continued growth of the industry. 

"What is important now is continued vigilance by the regulators and strict enforcement of the testing requirement," added Pasricha.

New quality controls remain limited in scope

Rajeev Jayadevan, former president of the Indian Medical Association in Kerala state, pointed out that making it compulsory to get a certificate of analysis from a government-approved laboratory would ensure the safety of the exported product and place the onus of quality control on the manufacturer.

"This is particularly pertinent because certain countries that import these products might not have robust quality verification systems in place," Jayadevan told DW.

"Besides the tragic loss of lives, the recurrence of these outcomes could disproportionately damage the reputation of the entire Indian pharmaceutical industry, impacting the business of even the most conscientious manufacturers," he added.

However, others have pointed to the lack of transparency and limited government response that is obscured by a complex inspection regime. The country has a huge network of some 3,000 drug companies and about 10,500 manufacturing units.

"Precious little will result from this move by the government," Dinesh Thakur, a public health activist focused on improving the quality of affordable medicines, told DW. "Cough syrups are a minuscule part of the pharma exports and the order from the Directorate General of Foreign Trade is limited to just these products and only for export.

"Patients within India who purchase cough syrups from these very companies continue to be subjected to substandard medicines. It is remarkable that these companies are required to get their products tested for export but have a free rein to sell their substandard drugs within the country," added Thakur, who has been advocating reform in India's drug regulatory system.

Others like Vikas Bajpai, a public health physician, said safety standards cannot be compromised at any level, adding that the lax regulatory mechanisms required stricter protocols.

"The instances of the tainted cough syrups bring to light the lacunae in quality control mechanisms at the production level itself. One can recall the quality issues with the manufacturing of India's homegrown COVID vaccine Covaxin where its export was impacted due to quality issues raised by WHO itself," Bajpai told DW.

"It's fine to [rest on] one's laurels, but only so long as they rest on due diligence. It is a matter of peoples' lives after all," added Bajpai.

India's pharma industry booming

In April, the leading drug regulatory body, Central Drugs Standard Control Organization, flagged 48 medicine batches out of a total of 1,497 samples for failing to pass random drug sample tests.

These flagged medicines include antidiabetic drugs, antibiotics, calcium and cardiac drugs, including some of the most popular medications on the market, such as epilepsy drug Gabapentin, hypertension drug Telmisartan, antidiabetic drug combination Glimepiride and Metformin and HIV drug Ritonavir.

The pharmaceutical industry is thriving, especially in the sectors of generic medicine and health care. Exports to Western countries have played a big role in the industry's growth.

India has often been referred to as the "pharmacy of the world," owing to its high and efficient production of global standard medicine at affordable costs.

According to the pharmaceutical industry, India meets global demand for over 50% of various vaccines, 40% of generic demand in the United States and 25% of all medicines in the United Kingdom.

Generic drugs account for 20% of the global export in terms of volume, making the country the largest provider of generic medicines globally.

Edited by: Alex Berry