The Indian government has suspended manufacturing in over 40 pharma companies based on a risk-based assessment conducted earlier in the year across 162 firms, according to the data provided by Union Health Minister Mansukh Mandaviya in Parliament on Thursday (Aug. 10).
“Overall, a sum of 143 show-cause notices has been issued,” Mandaviya said.
There have been numerous recent incidents involving accusations from foreign countries regarding the contamination of syrups, eye drops, and ointments manufactured in India. Countries such as the Gambia, Uzbekistan, and Cameroon have linked the deaths of 70, 18, and six children, respectively, to cough syrups contaminated in India.
Licenses for specific products have been either temporarily suspended or fully revoked for an additional 66 companies. In one case, an FIR has been registered, and in 21 cases, warning letters have been issued following inspections by both the Central Drugs Standard Control Organization and State authorities, the Minister added.
Meanwhile, the Indian government has mandated rigorous testing for cough syrups before export. Starting June 1, any cough syrup must possess a government laboratory-issued certificate of analysis before being exported, the government said in a notice dated May 22.
Good manufacturing practices
The Health Minister recently met with representatives from pharmaceutical companies in the MSME sector and underscored the importance of self-regulation in drug manufacturing to maintain quality standards.
The Minister also encouraged pharmaceutical firms to embrace Good Manufacturing Processes (GMP) in drug manufacturing, aligning with international standards set by the World Health Organization. Currently, just 2,000 out of India’s 10,500 manufacturing units adhere to these standards, the Minister said.
Pharmaceutical sector experts support the implementation of the new GMP outlined in a 2018 draft of Schedule M, noting it will not only enhance the quality of exported drugs but also establish the same standard within India.
The government has firmly instructed larger pharmaceutical companies, with a turnover exceeding £29 million (Rs 250 crore), to adopt these measures within six months, while smaller firms are granted a year for compliance.
‘3% of medicines deemed substandard’
In the July parliamentary session, Bharati Pravin Pawar, Minister of State for Health, revealed that “out of the total 84,874 drug samples tested in 2020-21, 2,652 samples (3.12 per cent) were deemed substandard, and 263 samples (0.31 per cent) were identified as spurious and adulterated drugs.”
The Minister emphasised on various regulatory measures taken to ensure medicine quality, which include notifications mandating the inclusion of barcodes or quick response codes in active pharmaceutical ingredients and specific drug formulations.
Furthermore, “drug marketers are now accountable for their product quality under a notification. Central drug testing labs were reinforced, and the Drugs and Cosmetics Rules were amended to require stability proof and excipient safety for manufacturing licenses,” she said.
The Central government allocated over £61 million (Rs 647.47 crore) to enhance the drug regulatory system, upgrading labs, setting up new testing facilities, and improving state drug control offices, the Minister added.
Health authorities are investigating an allegation that a local pharmaceutical regulator in Haryana facilitated the substitution of cough syrup samples, potentially linked by the World Health Organization (WHO) to children’s deaths in Gambia, for testing at an Indian laboratory, reportedly in exchange for a bribe.
India’s expansive pharma basket
India presently holds a 5.92 per cent stake in the global pharmaceutical and drug market. Despite challenges, the country’s pharmaceutical exports have sustained their upward trajectory, amounting to $25.3 billion for the fiscal year 2022-23, according to data from the Pharmaceuticals Export Promotion Council of India (Pharmexcil), a division of the Ministry of Commerce and Industry.
India dominates vaccine export, meeting 65-70 per cent of WHO’s demand, recent data showed. The country’s exports consist of formulations and biologics, accounting for 73.31 per cent, followed by drug intermediates and bulk drugs. Of the global generics, eight in twenty are Indian, with over 55 per cent of exports focused on regulated markets.
“Despite varying growth rates throughout the year, marked by growth in eight months and a decline in four, the industry still achieved a 3.25 per cent increase from the previous fiscal year’s $24.5 billion,” said Ravi Udaya Bhaskar, Director General of Pharmexcil. “The U.S., Belgium, South Africa, the UK, and Brazil remained the top five pharma importers.”
The U.S., India’s largest pharmaceutical products exporter, also reported three deaths linked to bacterial contaminants in over-the-counter eye drops manufactured in India.
In 2021-22, the U.S., the UK, and Russia were prominent importers of Indian pharmaceutical products, representing 29 per cent, 3 per cent, and 2.4 per cent respectively. India’s pharmaceutical exports to these nations were as outlined: the U.S. at $7,101.6 million, the UK at $704.5 million, South Africa at $612.3 million, Russia at $597.8 million, and Nigeria at $588.6 million.
