Challenges Faced by MSME Pharma Industries on Revised Schedule M

The new Schedule M mandates pharma units to produce drugs meeting WHO/Western Standards within the next 6-12 months

January 11, 2024

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Last Updated on January 17, 2024 by The Health Master

Schedule M

In recent developments, the Small and Medium Enterprises (SME) pharma industries in the country find themselves at a crossroads, grappling with the implications of the revised Schedule M issued by the Ministry of Health.

This move has triggered concerns about the survival of thousands of Micro, Small, and Medium Enterprises (MSME) pharma units, ultimately impacting the availability of affordable drugs in the market.

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Erstwhile Schedule M vs. Revised Schedule M

The erstwhile Schedule M, considered adequate for maintaining quality standards, is now being questioned.

Rather than introducing sweeping changes in the law, industry stakeholders argue that the government should focus on holding the drug regulator accountable for effective implementation.

The SME Pharma Industries’ Confederation (SPIC) asserts that the new Schedule M, if not implemented judiciously, could lead to irreparable losses and the closure of numerous MSMEs.

Compliance Challenges

The new Schedule M mandates pharma units to produce drugs meeting WHO/Western Standards within the next 6-12 months.

However, compliance seems feasible only for a limited number of WHO Good Manufacturing Practice (GMP) Certified Units in the country.

These units, constituting around 1,350, export drugs at higher prices to cover the costs of superior facilities, equipment, documentation, testing, and GMP procedures.

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Impact on Affordability and Accessibility

The Confederation highlights a critical concern – compliance by the remaining 10,000 units may prove challenging due to prevalent price controls and the lack of affordability among consumers.

This, in turn, could render approximately 70% of National List of Essential Medicine (NLEM) drugs financially unviable, as the cost of production would exceed the ceiling price.

The Punjab Conundrum

Notably, the representation to the Prime Minister sheds light on the specific challenges faced by units in states like Punjab, where compliance with the new Schedule M is a daunting task.

The closure of over 10,000 units nationwide, including those in Punjab, could potentially render millions jobless, impacting not only direct employment but also ancillary industries and channel partners connected to MSME sales.

Skill Gap and Training

The article delves into the issue of a significant skill gap in the pharmaceutical industry. Existing institutes are failing to produce manpower tailored to industry needs.

The lack of training for documentation, coupled with the high cost of skilled manpower mandated by the new regulation, is a burden that many MSMEs cannot afford.

Water Quality Concerns

The Federation draws attention to the oversight regarding water quality as per WHO guidelines.

While there are provisions for pharmaceutical quality, the issue of large quantities of non-potable water being used remains unaddressed, raising concerns about the quality of the final product and its impact on public health.

The Root Cause

The Federation, emphasizing that changes in laws, especially those without tangible benefits for consumers or quality improvement, have adversely affected the industry.

It calls for fixing responsibility rather than targeting the industry as a whole.

A Plea for Balanced Regulation

In conclusion, the SME pharma industries urge Prime Minister Narendra Modi’s intervention to address the challenges posed by the revised Schedule M.

Balancing the need for quality with the economic survival of MSMEs is crucial for the continued availability of affordable drugs in the market.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.