Govt to review product quality of PLI scheme beneficiaries

The Department of Pharmaceuticals (DoP) under the Government of India has asked state drug controllers to review the product quality and manufacturing units of companies benefiting from the central government’s Product Linked Incentive Scheme (PLI) for medicines.

The decision was taken in the wake of the Delhi-based Maiden Pharma cough syrup controversy that killed 66 children in the Gambia. Terming the development a “wake-up call” for the Indian pharmaceutical industry, officials in the DoP have asked states to verify whether products manufactured and exported from pharmaceutical companies fall under Micro, Small, and Medium Enterprises (MSME). -PLI Scheme.

“PLI incentives are based on incremental sales and manufacturing quality is only the concern of the Central Drugs Standard Control Organization (CDSCO) and state regulators. Further, the PLI scheme is extended only to those who manufacture quality products [and] follow good manufacturing practices. However, under the PLI scheme, We want to verify the manufacturing units and standards of the products that these existing units export or sell domestically,” a senior government official told BT.

The Indian pharmaceutical industry is the 3rd largest in the world by volume and $40 billion in value terms. The country accounts for 3.5 percent of the total drugs and medicines exported globally. India exports pharmaceuticals to more than 200 countries and territories, including highly regulated markets like the US, 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 of high-value goods in the pharmaceutical sector. The scheme aims to create global champions out of India who has the potential to grow in size and scale to penetrate the global value chains. 

“We need to ensure we are exporting products that meet global standards. We should also review that we have drug inspectors to do the job,” said the official cited above.

Meanwhile, 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 of the Authentication Solution Providers’ Association (ASPA).

Industry experts as well as pharmaceutical associations have also raised concerns about the image of MSMEs in the global market. “It is a lesson for Indian regulators to examine promoters’ motives and company track record in domestic as well as export markets to stop this type of incidents in the future. The regulators should verify the last 5 to 10 years of the company’s track record. No manufacturers wish to do the same but the 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 a 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 product 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 the 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 the 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.”