India aims to tighten quality of drugs

Issues according to the ministry, which inspected over 160 units and 14 public testing labs range from poor documentation, absence of testing incoming raw material, quality failure investigation, professionally qualified employees amongst others.

Companies have been given six to 12 months to adhere to requirements starting August 1. Companies with a turnover of over Rs 250 crore will be given six months and those with a turnover of below Rs 250 crore 1 year to comply to standards. The certification will be valid for 3 years.

While this step is expected to be positive especially at a time when Indian companies have been in the dock due to recent global incidents of substandard drugs, there are some concerns point out experts.

For example, one of big concerns is that currently the pharma companies come under the purview of state regulators. Hence the power to issue or cancel licenses is with state governments. The concern then is that the central government does not have the power to implement the compliance standards.

Also, while Schedule M became mandatory in the law in 2005 companies have struggled to implement it for the last 18 years. Many of the smaller companies for example might need to upgrade their existing facilities to comply with the standards, to do so they will require capital and infrastructure, which they might lack. An example of this is quality control labs, which were made compulsory in 2005 but companies did not comply due to inability to afford setting up the units.

Lastly, the timelines of 6 months to 1 year might not be feasible for the large number companies to adhere to the standards. India currently has around 10,500 drug manufacturers including MSMEs but only 2,000 companies mainly exporters are expected to have a good manufacturing certificate. That means 8,000 companies needing to comply to standards set out in Schedule M in just the span of a year might be a tall task.