India mandates compulsory testing for the export of cough syrups starting June 1.
Health Minister Mansukh Mandaviya declares zero tolerance for counterfeit medicines and issues show-cause notices to 71 companies implicated in contaminated cough syrup-related deaths, with 18 businesses instructed to cease operations.
During an interview, the Minister emphasized that continuous comprehensive risk-based analysis is conducted to guarantee the production of high-quality medicines in India. The government and regulatory authorities remain vigilant to prevent any fatalities caused by counterfeit medications.
The Minister stated, “As the world’s pharmacy, we aim to be recognized as the global benchmark for quality.”
In February, Global Pharma Healthcare, a Tamil Nadu-based company, completely recalled its eye drops. Before that, India-made cough syrups were reportedly associated with the deaths of at least 70 children in Gambia and 18 children in Uzbekistan in the previous year.
India’s cough syrup exports reached a value of $17.6 billion in 2022-23, surpassing the $17 billion mark in 2021-22. Overall, India is the largest global supplier of generic drugs, catering to over 50% of global vaccine demand. Approximately 40% of generic demand in the U.S. Additionally, India supplies about 25% of all medicines in the U.K.
Mr. Mandaviya emphasized the importance of investigating facts whenever questions arise regarding Indian medicines. In the case of Gambia, where it was reported that 49 children had died, the Minister revealed that they had reached out to the World Health Organization (WHO) seeking clarification but received no response regarding the actual facts of the situation.
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Regarding the investigation, Mr. Mandaviya stated that they examined the samples from one company and found that the cause of death in one case was diarrhea. He questioned the recommendation of cough syrup for a child with diarrhea, highlighting the need for proper assessment. The Minister added that 24 samples were tested, out of which four failed the quality standards.
Addressing concerns, Mr. Mandaviya explained that if a single batch of cough syrup meant for exports fails the quality standards, all samples from that batch would be deemed as failed. He emphasized that it is implausible for 20 samples to pass while four samples fail. Nevertheless, the government remains vigilant and conducts ongoing risk-based analysis to ensure the production of high-quality medicines in India.
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Since June 1, India has implemented mandatory testing for cough syrups before they can be exported. According to a notification by the Directorate General of Foreign Trade (DGFT), cough syrup exporters must present a certificate of analysis issued by a government laboratory before export.
Mr. Mandaviya affirmed that extensive risk-based analysis has been conducted at over 125 companies, with official teams inspecting their facilities. As a result, show-cause notices have been served to 71 companies, and 18 of them have received closure notices.
The Minister assured the global community that India will never compromise on the quality of medicines, adhering to a strict zero-tolerance policy towards counterfeit drugs. He emphasized that spurious medicines will be treated with the same severity as done internationally, and the government remains constantly vigilant to prevent any fatalities caused by such medicines.
The modification in the export policy was prompted by global concerns regarding the quality control of cough syrups exported by Indian companies.
In response to the new policy, the Drugs Controller General of India (DCGI) instructed designated State and Central laboratories to prioritize testing samples from cough syrup manufacturers intended for export. The objective is to promptly generate test reports.
The specified Central Government laboratories include the Indian Pharmacopoeia Commission, the regional drug testing lab (RDTL) in Chandigarh, the central drugs lab (CDL) in Kolkata, the central drug testing labs (CDTL) in Chennai, Hyderabad, and Mumbai, the RDTL in Guwahati, as well as the drug testing labs accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) within State governments.
India holds the third position worldwide in pharmaceutical production volume and ranks 14th in production value.
The Indian pharmaceutical industry plays a significant role as a manufacturer and exporter of medical products to a diverse range of countries, encompassing both highly developed nations and low- to middle-income countries (LMICs).
Comprising a vast network of 3,000 drug companies and approximately 10,500 manufacturing units, the industry ensures the global availability and distribution of affordable, high-quality medicines. India holds a crucial and esteemed position in the global pharmaceutical sector.
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