Why you may not get some medicines in market now?
The Union health ministry has notified revised schedule laying down sound manufacturing practices. Stipulations for requirements of factory premises, plant and equipment with provisions for an annual product quality review have been laid down.
There is turmoil in the pharmaceutical industry with associations of small and medium enterprises in this domain alleging that they cannot follow the rules recently announced by the Union health ministry that might force some units to shut shop eventually leading to the rise in prices of drugs and, in some cases, even shortage of medicines. The Economic Times has reported that the trouble revolves around Schedule M.
The Union health ministry has notified revised schedule laying down sound manufacturing practices. Stipulations for requirements of factory premises, plant and equipment with provisions for an annual product quality review have been laid down. Also included are quality risk management and pharmaceutical quality systems.
The government has stipulated that Schedule M would be applicable to all companies irrespective of their size. None other than the Union health minister Mansukh Mandaviya said in July 2023 that it would mandatorily apply to the MSME units in the pharmaceutical units in phases. He said that companies with turnover less than Rs 250 crore would get one year to implement it – in other words, by July 31, 2024. Those with turnover above Rs 250 crore have to comply within six months.
But industry bodies think compliance might be difficult.
Sanjay Singla, a representative of Laghu Udyog Bharti (LUB), an association of small businesses which is an affiliate of the Rashtriya Swayamsevak Sangh (RSS) said that the small and mediuk entities would find it very tough to implement the provisions in revised Schedule M. The upgrade will come at a high cost.
“In the process many units will see closures, resulting in drug prices going up and shortages. The implementation of the new norms would be challenging for smaller firms, which may lead to a rise in near term capex and a permanent increase in operating costs,” Singla remarked.
Punjab Drug Manufacturers’ Association (PDMA) functionaries have said that manufacturing of National List of Essential Medicines will not be possible after complying with these regulations. If these norms are obeyed, these drugs, which are under price control, will become unviable as the cost of producing them will be more than the ceiling price.