RSS affiliate Laghu Udyog Bharati bats for Indian SME pharma companies; seeks directives to strengthen quality drug production, exports

Almost 11 months after the Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO), directed pharmaceutical companies to conduct bio-equivalence (BE) studies as a condition for continuing to manufacture certain types of medicines that have been approved and marketed in India for two to three decades, small and medium scale (SME) drug makers say they continue to face practical challenges in complying with the mandate.  

In a representation to Union Health Minister J P Nadda, SME industry body Laghu Udyog Bharati (LUB)  said Indian pharma SMEs are struggling to comply with the directive due to limited capacity available for conducting BE studies in India and high cost involved, approximately Rs 25 lakh to Rs 50 lakh per product. “Through this circular, repetitive studies will be invited for existing 10,500 industries”, LUB, the SME industry association affiliated to the ruling BJP’s ideological parent Rashtriya Swayamsevak Sangh (RSS), said.

The LUB representation sought re-notification of the nine- year old directive to see that the BE requirement is implemented on prospective basis, thereby ensuring the quality of new medicines that are introduced in future. The industry body also called for a 10 year road-map for further investment and adoption of Central government’s innovation-related schemes in the pharmaceutical sector.

The industry body urged the government to compile a list of pharmaceutical products banned in countries where Indian medicines are currently exported. Once such a list is available, Indian manufacturers can avoid exporting those products to respective markets, thereby eliminating the need to obtain no-objection-certificates from the drug regulators of individual countries before shipment of medicines, it said.

The industry representation also said that the monthly publication of “not of standard quality (NSQ)” drug list often leads to undue harassment of genuine SMEs, while the ‘black sheep’, the suppliers of spurious drug suppliers, are not always subjected to adequate investigation. To have in place a fair and transparent mechanism in place, the LUB wanted the government to publish a Standard Quality Drug List also, along with the NSQ list, on a monthly basis.

LUB is a representative body of more than 1260 MSME pharma manufacturers across India.