Schedule M norms

Schedule M norms

Subject : Science and Technology

Section : Health

Context: In just six months, reports of three major global incidents, including deaths, have been potentially linked to pharmaceutical products sourced from India. The incidents, have put local manufacturing practices and supply chain management under fresh scrutiny

Content

After incidents of deaths reported recently a policy directive is being discussed to “upgrade” present manufacturing practices to the World Health Organization’s cGMP (current Good Manufacturing Practices) levels. But not everyone is convinced that such “upgradation” would ensure quality products are supplied in the country and outside. Especially, since some of the companies in the dock now are reportedly WHO-GMP compliant.

The present Schedule M norms for manufacturing are stringent, and sometimes all that’s needed is technical hand-holding by regulators, or financial help to upgrade systems and documentation.

Schedule M norms:  It is good manufacturing practice norm.