CDSCO panel seeks uniform enforcement of drug standards across states

The DCC has asked the Centre to address gaps in drug-standard enforcement, write to states on non-uniform norms and improve testing and regulatory infrastructure highlighted under the SHRESTH index

In a move to ensure effective enforcement of medicine standards nationwide, the Drug Consultative Committee (DCC) has recommended to the Centre to take steps against non-uniformity in implementation of these norms in several states.

 

DCC is a statutory body under the Central Drug Standards Control Organisation (CDSCO).

 

In its 67th meeting held on November 17, the DCC suggested writing to all states to take proactive steps to address issues. These include non-uniform implementation of prescribed drug standards and lack of testing facilities. It sought necessary infrastructure as highlighted under the Centre’s State Health Regulatory Excellence Index (SHRESTH).

 

SHRESTH is a virtual gap tool for states to evaluate their current status and progress towards maturity certification. It is aiming to ensure drug safety, quality and efficacy across all states and Union Territories (UTs). 

 

According to the minutes of the meeting, seen by Business Standard, the DCC stated that some states are lagging behind in the uniform implementation of prescribed drug standards, testing facility of laboratories and skilled development of staff. 

 

The lack of uniformity in drug standards among states has been in discussion ever since several cases of deaths due to intake of contaminated oral formulation, such as cough syrups, came to the fore in October. 

 

Another big issue is the low conviction rate due to reasons like insufficient investigations, delay in testing results and ineffective prosecution services.

 

The minutes of the DCC meeting added that states may also be asked to implement rigorous scrutiny of adulteration in imported pharmaceuticals products. 

 

This comes after the Drugs Controller General of India (DCGI) asked all state licensing authorities (SLAs) to start preparing to conduct inspections at pharmaceutical manufacturing units. It is to verify their compliance with the revised Schedule M, which advocates good manufacturing practices (GMP).

 

 The DCGI has also requested all states and UTs that have not boarded the Online National Drugs Licensing System (ONDLS) to register. This is to streamline drug licensing and regulatory compliance. 

 

According to officials, only 18 state and UT drug control authorities have onboarded the portal. 

 

ONDLS is a digital, single-window platform for processing various drug-related licences in India.