Amid the allegations of contaminated eyedrops exported to the Sri Lankan market by Gujarat-based Indiana Ophthalmics, India’s apex pharmaceuticals export council has sought “an explanation” from the company on the internal investigation within the next two days, News18 has learnt.
On June 1, News18 reported that the Central Drugs Standard Control Organisation (CDSCO) is investigating a complaint raised by the Sri Lankan ministry of health where India-made eyedrops are linked to causing eye infections in more than 30 people in the island nation.
Pharmexcil— an agency that functions under the ministry of commerce and industry — wrote a letter to managing director Nirav R Bhatt on June 1.
The letter, accessed by News18, mentions that the company has been registered with Pharmexcil as a small-scale manufacturer.
The letter written by Udaya Bhaskar, director general of Pharmexcil, blames the firm for bringing “bad reputation” and causing “trust deficit”.
“Alleged supply of contaminated eyedrops by your company has brought a bad reputation to the Indian pharma industry and is also likely to have an impact on the trust of international agencies on Indian pharma export, ” Bhaskar said in the letter.
The company has been advised to “investigate the reasons for contamination of the alleged product at your end and update us with your findings at the earliest to take necessary action”.
Pharmexcil has warned the company of suspending its export licence.
“Upon failure of submission of requested information by 3 June 2023, your registration cum membership certificate (RCMC) will be suspended without any further notice,” the letter said.
Alarmed by the series of lapses in the making of medicines — highlighted by global drug regulators including the World Health Organization — Pharmexcil has been aggressively pushing the health ministry for fixing the gaps in good manufacturing practices at Indian pharmaceutical firms.
The move, once again, puts a question mark on the manufacturing quality of made-in-India medicines. Starting October 2022, multiple allegations have been levelled by importers of Indian medicines, especially cough syrups, including Uzbekistan, the Gambia, Marshall Islands, and Micronesia, where made-in-India syrups were found contaminated with toxic diethylene glycol (DEG) and ethylene glycol (EG).
In February, the US Food and Drug Administration had warned against using an India-made eyedrop that was linked to the outbreak of a drug-resistant bacteria.
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