Small drugmakers in India fear possibility of new manufacturing measures 'crippling' them

Groups said to be calling for further delays in implementation.

Micro, small, and medium enterprises (MSME) in India's pharmaceutical sector want a lot more time before new good manufacturing practice (GMP) standards take effect.

Data and analytics firm GlobalData noted: "Reportedly, MSME associations have appealed to the Union Health Minister to hit the brakes on new stringent manufacturing rules imposed by the Central Drugs Standard Control Organisation (CDSCO).

"They warn that abrupt implementation timelines – especially the revised Schedule M GMP requirements and mandatory bio-equivalence studies for all generics – could financially cripple small drugmakers and force many to close, risking shortages of generic and critical medicines."

It was highlighted that the deadline had already been pushed back several times. It's currently set at 1 January 2026, more than a year earlier than the preferred April 2027 (or beyond) timeline.

"MSMEs argue that these quality‑focused measures disproportionately strain them compared with multinationals, threaten competitiveness in domestic and export markets (such as Bangladesh, Sri Lanka, and China), and could lead to market exits and shortages of critical therapies, including oncology and cardiovascular medicines," said GlobalData Research Analyst Leyla Hasanzadeh.

According to GlobalData, small drugmakers in India are facing high compliance costs as well as additional pressure from other regulations such as tougher penalties for quality failures and revised rules for gene therapies.