HPMA Urges Health Minister to Halt Risk-Based Inspections by Drug Regulatory Authority

The objective is to address the concerns raised and establish a more supportive framework for the industry without compromising public health standards.

The Haryana Pharmaceutical Manufacturers Association (HPMA) has urged Health Minister Mansukh Mandaviya to temporarily halt the risk-based inspections at the Micro, Small, and Medium Enterprises (MSMEs) units carried out by the drug regulatory authority.

This plea comes to light after several Micro, Small, and Medium Enterprises (MSMEs) units received cease production orders from the drug authority due to the manufacturing of substandard drugs.

The HPMA not only urges the Minister's intervention in this matter but also emphasises the need for regulatory officials to transition into facilitators for the small and medium-scale industry.

On the issue, RL Sharma, president, HPMA, said, "We had met the minister and urged him to help the MSME sector. We want the officials at the regulatory body to become facilitators for the small and medium scale industry and handhold us."

The objective is to address the concerns raised and establish a more supportive framework for the industry without compromising public health standards.

What Led to the Regulatory Inspections?

The MSME sector, often referred to as the ‘backbone’ of India’s economy, has been hit hard by various inspections. Government data reveals nearly 8,000 MSMEs shut in FY23 so far.

In December 2022, the government launched the risk-based inspections of MSMEs. The inspections were driven by concerns about the quality of drugs, as substandard drugs can greatly worsen ailments, help them spread, or make them drug-resistant.

The move to inspect the quality of medicines produced by small companies in India was initiated as part of a nationwide crackdown on spurious and substandard drugs. The Central Drugs Standard Control Organisation (CDSCO), along with state drug inspectors, has been carrying out these inspections.

Recently, the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945, were notified in the Gazette of India to bring better compliance with quality standards. The focus was on risk management, qualification and validation of equipment, and self-inspection.

MSME Sector: Facts & Observations

As per a recent survey, more than 15% of medicines produced by small companies in India failed to meet quality standards compared with the national average of about 2%.

Further, in the government's latest risk-based inspections of MSME - which have been on since December 2022 - 41 (15.1%) were declared to be Not of Standard Quality (NSQ) out of the 271 samples analysed.

Reportedly, the share of nonstandard quality medicines manufactured in micro, small and medium enterprises (MSME) is seven times more than the national average.

The recent inspections and cease production orders are impacting the operation and survival of many MSMEs. With the request, the HPMA seeks to help the MSME sector recover.

Emphasising the necessity of halting the risk-based inspections temporarily, Sharma said, “The MSME needs time to upgrade as it requires funds and the government should help the sector."

Earlier, the Union Ministry of Communications, through the Department of Posts, launched the Dak Ghar Niryat Kendra (DNK) portal, aimed at simplifying the process of pharmaceutical exports for Micro, Small, and Medium Enterprises (MSMEs) to various countries. This initiative is set to benefit commercial customers and MSMEs by providing a seamless platform for exporting goods globally.

DNK, designed exclusively for commercial customers and MSMEs across the nation, aims to make "Exports Made Easy" for these enterprises. One of the key advantages of the portal is the reduction of expenses on third-party software for tasks such as generating invoices and Postal Bills of Export (PBE).

Exporters can now handle all export-related tasks from the comfort of their homes, resulting in considerable time savings. Additionally, the portal enables a reduction in printing costs for barcodes and lowers expenses on Customs House Agents (CHA).