Drug contamination reports hurt Indian pharma, government must find a way: Experts

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Reports of contaminated cough syrups supplied by Indian pharma companies resulting in the death of children in two countries should serve as a warning to the union government, which boasts that the country is the pharmacy of the world, experts said.

Rajiv Gulati, former President, Ranbaxy Laboratories, said the time had come for the government to tighten the regulatory framework for pharma manufacturers in the country. “These reports damage our reputation,’’ he added.

“India has the largest number of drug manufacturers. The challenge is to ensure that the manufacturers observe Good Manufacturing Practices (GMP) irrespective of the size of their operations,” Gulati told Moneycontrol.

Also read: Uzbekistan Cough Syrup Deaths: Pharmexcil suspends membership of Marion Biotech

The former Ranbaxy president said that the government and the regulators must act quickly to ensure that all manufacturers follow a minimum standard while exporting drugs abroad.

“The regulatory authorities of the importing country should also check the products before releasing them into the market,” he added.

The All-India Organisation of Chemists and Druggists (AIOCD) said that reports about adulterated drugs had shaken the faith in medicines sold in India as well.

Also read: Exclusive | Uzbek Cough Syrup row: Drug regulators inspect Marion Biotech's manufacturing site

“The government needs to be aware that complaints like these hurt India’s image. The chemists and druggists are also impacted. There should be a mechanism for instilling confidence in the drugs sold here,” said AIOCD General Secretary Rajiv Singhal.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) suspended Marion Biotech with immediate effect after the company failed to reply to the council on the reported deaths.

The suspension means that the company's exports will become ineligible for incentives under the Market Access Initiative Scheme.

Dedicated committee

A senior Central Drugs Standard Control Organisation(CDSCO) official said that after reports of drug contamination from Gambia and Uzbekistan, the government was working on forming a committee with representatives from different departments to expedite the complaint redressal mechanism.

“The formation of an inter-ministerial committee for faster disposal of complaints is being considered,” the official added.

Also read: Uzbekistan cough syrup row: Marion Biotech asked to completely halt drug production at Noida plant

Singhal said that such a committee would be a welcome step. “The committee can do a periodic assessment of the drugs being exported and address both domestic and international complaints about contamination,” he added.

A four-member panel under Dr Y K Gupta had been tasked by the government to investigate the deaths of Gambian children purportedly due to the consumption of contaminated cough syrups supplied by Maiden Pharma. It is not clear whether the same committee will also probe the reported deaths of children in Uzbekistan. Dr Gupta is the Vice-Chairman of the standing national committee on medicines.

Pharma industry at stake

In October, the Gambian authorities had said that four types of contaminated cough syrups supplied by Sonepat-based Maiden Pharma had led to the death of 67 children.

After testing the control samples of the cough syrup batches supplied to Gambia, the Indian government had said that there was no contamination in the medicines and had reprimanded the WHO for “tarnishing the image of India’s pharmaceutical industry.’’

Also read: Gambian children’s death: Maiden Pharma’s cough syrups of standard quality, no contaminants found, says govt

However, the reported deaths of 18 children in Uzbekistan due to the consumption of contaminated cough syrups supplied by Noida-based Marion Biotech `are of concern’ as India views it as a huge market for exports of oncology and dermatology products, according to a health ministry official.

According to the United Nations COMTRADE database on international trade, India exported pharmaceutical products worth $137 million to Uzbekistan in 2021. The size of Uzbekistan’s overall pharma market is about $1.5 billion.

The health ministry official said India’s pharmaceutical exports to Uzbekistan more than doubled in FY2020-21.