Veena Kumari’s son, Anirudh, died from kidney failure after consuming contaminated cough syrup. © Reuters
RAJASTHAN, India — India has given small and midsize drug manufacturers another year to comply with international standards, a move that experts say further dents the reputation of an industry whose products have been linked to deaths across the world.
New Delhi said last month it would delay to the end of 2025 the implementation of a new regulation designed to bring pharmaceutical companies with annual turnovers of under $29 million on par with the World Health Organization’s “good manufacturing practices.”
The move to clean up the industry took on fresh urgency after the deaths of 70 children in Gambia and 18 in Uzbekistan in 2022 were linked to the consumption of cold and cough syrups originating in India. Before that, at least 16 children in India died under similar circumstances.
India implemented in December 2023 a redrafted regulatory framework that covered every aspect of manufacturing — premises, technology, documentation, indoor air quality and instrumentation — to comply with WHO standards.
Given that Indian manufacturers account for 40% of the generics supply in the U.S. and about 25% of all medicines in the U.K., the delay has wide-ranging impact.
It “poses concerns for the world,” said Umesh Baikunje, founder and CEO of Baikunje Consultancy, an auditing and training company focused on the pharmaceutical industry. “Delaying compliance can impact the 100% certainty of the quality of medicines by allowing substandard manufacturing practices to continue. Substandard manufacturing practices can, in turn, lead to contamination, inconsistent active ingredients and other quality issues.”
About 2,000 big pharmaceutical manufacturers were initially given six months ending June 2024 to comply, while 8,500 micro, small and midsize enterprises (MSMEs) had until the end of December.
Barely 2,000 producers had complied with the WHO guidelines by then, according to India Brand Equity Foundation, an initiative of the Ministry of Commerce and Industry. The cost of implementation had been a major challenge for these companies.
Chandni Hussain, an India-based senior analyst in the health care and life sciences department of U.S. research company Frost & Sullivan, said the delay could worry global regulators, given the previous problems.
“It could affect global confidence in the Indian active pharmaceutical ingredients and generics market,” Hussain told Nikkei Asia.
India’s larger pharmaceutical manufacturers outsource much of their production to smaller and midsize producers. Baikunje said about 90% of domestic demand and up to 45% of exports are made by local small and midsize producers.
“For bigger companies and multinational companies that outsource to MSMEs, any slipups in quality due to noncompliance can lead to severe consequences including product recalls, import bans and damage to their reputation,” he said. “If MSME units do not adhere to WHO standards, it could result in cross-contamination, mislabeling and inconsistency in active ingredients, all of which can have fatal consequences, as seen in past incidents involving contaminated cough syrups.”
Grieving parents in Gambia hold up signs during a news conference in November 2022 calling for justice for the children whose deaths were linked to contaminated cough syrups. © ReutersIndia is often called the “pharmacy of the world” because it exports drugs to around 200 countries and territories, with the top destinations being the U.S., Belgium, South Africa and the U.K.
In the fiscal year ended March 2024, India exported $26.5 billion worth of pharmaceuticals, accounting for more than half of its total of $50 billion, figures from the Ministry of Chemicals and Fertilizers showed.
Another analyst said, though, that the impact on other markets may be limited.
“Exports are governed by the rules and regulations of the importing country, and so, the delay in implementing reform may not directly impact global markets where quality is stringently audited, implemented and monitored,” said Atul Shirgaonkar, CEO of Insight Systems, a pharmaceutical auditor and trainer.
But Hussain said regulators may intensify scrutiny, which could create barriers and affect “India’s long-term credibility in regulated and semi-regulated markets.”
India also cannot afford to take a reputational hit when the pharmaceutical industries in China, Bangladesh, Africa and South America are increasingly competitive.
Mohan Ramaswamy, CEO of Rubix Data Sciences, a company assessing the credit, supplier and compliance risk of businesses, said India should mitigate concerns and reinforce its commitment to quality and patient safety by clearly communicating timelines around the implementation of new rules, and stick to them.
Bejon Misra, founder of lobby group Patient Safety and Access Initiative of India, cited the track and trace system for drug exports that was introduced in 2016. It was intended to weed out inferior products, but has yet to be implemented.
“In the interest of patient safety, there should be a limit to how much extension is given for the implementation of much-needed regulatory reform,” Misra said.
source : asia.nikkei