The Department of Pharmaceuticals (DoP), under the government of India, has asked the state drug controllers to review manufacturing units and product quality of the companies benefitting from the central government run Production Linked Incentive Scheme (PLI) for pharmaceuticals.
The move follows the controversy surrounding Delhi-based Maiden Pharma’s cough syrups, which have been linked to deaths of over 66 children in Gambia. Calling the development a “wake up call” for Indian pharmaceutical industry, officials in the DoP have also urged the states to verify, if the products manufactured and exported from pharmaceutical companies come under the Micro, Small and Medium Enterprises (MSME) comes -PLI scheme.
“PLI incentives are based on incremental sales and the quality of manufacturing is related only to Central Drugs Standard Control Organisation (CDSCO) and State regulators. Further, the PLI scheme is extended to only those who manufacture quality products, [and] follow good manufacturing practices. However, we want to verify and double check the manufacturing units and standard of the products exported or sold domestically through these units under the PLI scheme,” a senior government official told BT.
Indian pharmaceutical industry is the 3rd largest in the world by volume and is $40 billion in terms of value. The country contributes 3.5 per cent of total drugs and medicines exported globally. India exports pharmaceuticals to more than 200 countries and territories, including highly regulated markets such as the US, The UK, European Union, Canada, etc.
The objective of the PLI scheme is to enhance India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector. The scheme aims to create global champions out of India who have the potential to grow in size and scale to penetrate the global value chains.
“We need to ensure we are exporting products that meet the global standards. We should also review that we have drug inspectors to do the job,” said the official cited above.
Meanwhile, the industry experts have said that there is a need for stricter regulatory processes even for the domestic markets. Moreover, there has been a demand for stricter authentication processes.
“In 2011, the Indian government implemented traceability solutions for exports and the pharmaceutical industry adheres to international standards and authentication protocols. Unfortunately, the domestic regulations and legal structures are not as well defined as required,” said Chander S Jeena, Associate Director, Authentication Solution Providers' Association (ASPA).
Industry experts as well as pharmaceutical associations have also raised concerns on the image of MSMEs in the global market. “It is lesson for Indian regulators to examine promoters’ motive and company track record in domestic as well as export market to stop this type of incidents in future. The regulators should verify last 5 to 10 years of company track record. No manufacturers wish to do the same but last 5 to 10 years of company track record are proof of quality manufacturing,” said Rajesh Gupta, All India Head Pharma wing, Laghu Udyog Bharati, New Delhi.
“India is a pharmacy of the world and such incidents dent existing players a bit, but handful of such incidents will not affect the long-lasting establishments,” said Gupta, while agreeing that sentiments of the industry were indeed hurt, and the incident involving Maiden has put the entire pharmaceutical industry is in a deep dilemma. Gupta maintains that the MSME players will take lessons and need to have a more focused analysis during products manufacturing and releasing them in the market.
The WHO on September 29 informed the c (DCGI), the national drug regulator of India, that it is currently providing technical assistance and advice to Gambia, where the significant contributing factor leading to the death of children was suspected to be the use of medicines which may have been contaminated with diethylene glycol or ethylene glycol. Last week, the global health body said that the deaths in Gambia could be linked to contaminated cough and cold syrups which were manufactured by Maiden.
The WHO, in a medical product alert, had said, "The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products."
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