HPMA’s Plea for Industry Relief

HPMA proposes an extension to a minimum of two years, providing the necessary breathing space for compliance

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Last Updated on January 5, 2024 by The Health Master

HPMA

The Haryana Pharmaceutical Manufacturers Association (HPMA) has recently appealed to Union Health Minister Dr. Mansukh Mandaviya, urging him to take decisive actions regarding the risk-based inspections (RBI) conducted by the Central Drugs Standard Control Organization (CDSCO) at the manufacturing plants of small and medium-scale pharma industries.

The association advocates for either a one-year suspension of these inspections or an extension of the deadline for the introduction of the Revised Schedule M by up to two years.

Introduction

In the complex landscape of pharmaceutical manufacturing, the small and medium-scale pharma industries play a crucial role.

However, recent developments, particularly the RBIs initiated by CDSCO, have raised concerns within the industry.

HPMA’s Appeal to Union Health Minister

Request to Suspend RBIs

HPMA leaders emphasize that the current inspections by CDSCO officials are causing more disruption than assistance to the industry players.

The Micro, Small, and Medium Enterprises (MSMEs) in the pharmaceutical sector require not only financial support but also an extension of the time-limit for complying with the new schedule.

Appeal for Extension of Revised Schedule M Deadline

The industry argues that the given deadline for the introduction of the new schedule is insufficient for small pharma manufacturers across India.

Therefore, HPMA proposes an extension to a minimum of two years, providing the necessary breathing space for compliance.

CDSCO

CDSCO’s Regulatory Role

While CDSCO is tasked with ensuring the quality and safety of pharmaceutical products, HPMA suggests a shift in focus.

The association recommends that CDSCO should act more as a facilitator and guide rather than solely as regulators.

MSMEs’ Need for Financial Support

Financial Challenges Faced by Small Pharma Manufacturers

HPMA highlights the financial challenges faced by small pharmaceutical manufacturers, necessitating immediate support from the government.

The transition to new guidelines and adherence to WHO Good Manufacturing Practices (GMP) standards require significant investments.

Extension of Time-Limit for Compliance

While CDSCO has given a one-year timeframe for MSMEs to improve their facilities, HPMA argues that this is insufficient.

The association advocates for a one-year suspension of inspections to allow the industry to focus on necessary improvements.

HPMA’s Delegation to Union Health Minister

Leadership of RL Sharma

A delegation from Haryana, led by HPMA president RL Sharma, met with Union Health Minister Dr. Mansukh Mandaviya to communicate the challenges faced by small industrial units in the state.

Presentation of Industry Challenges

During the meeting, RL Sharma expressed the industry’s concerns, emphasizing the need for CDSCO to guide and support the pharma MSMEs over the next year rather than acting as regulatory officers.

CDSCO as Facilitator and Guide

HPMA’s Perspective

Sharma asserts that CDSCO should act as a facilitator and guide, providing valuable support to the pharma MSMEs for the next year.

The industry requires assistance, not additional regulatory pressure, to meet the new standards.

Request for Guidance Instead of Regulation

The focus should be on guiding the industry through the transition, offering valuable insights and support rather than enforcing regulatory measures that hinder progress.

Government Support

Industry’s Need for Financial Assistance

HPMA emphasizes the urgent need for financial support from the government to improve infrastructure facilities according to the new guidelines and WHO GMP standards.

Infrastructure Improvements as per WHO GMP Standards

The industry’s adherence to international standards is crucial, and financial support will enable small pharma manufacturers to enhance their facilities and meet the required standards.

Minister’s Assurance and Encouragement

Minister’s Keen Interest in Industry Concerns

During the meeting, Minister Mandaviya assured the delegation that he would carefully consider the challenges raised by the industry leaders.

He expressed a keen interest in addressing the concerns and encouraged a gradual improvement of facilities.

Encouragement for Quality Pharmaceutical Manufacturing

The minister emphasized the importance of manufacturing quality pharmaceuticals and offered support and help to the pharma MSMEs in Haryana.

Positive Responses and Financial Support

Hopeful Outlook for Positive Ministerial Responses

HPMA expresses optimism regarding positive responses from the minister’s office, anticipating solutions to the challenges faced by the industry.

Financial Support for Transition to New Schedule

In addition to addressing regulatory concerns, the delegation sought financial support for the industry’s transition from the existing standards to the new schedule.

Additional Demands by HPMA

Retention of CDSCO’s Office in Ghaziabad

HPMA also requested the minister to retain CDSCO’s office in Ghaziabad, citing its strategic location near Karnal, the pharma hub in Haryana.

Geographical Advantage of Ghaziabad for Pharma Hub

Ghaziabad’s proximity to Baddi and Sonipat, other pharma centers in the northern parts of the country, makes it an advantageous location for CDSCO’s office.

Minister’s Advice on Quality Focus

Minister’s Guidance on Medicine Quality

Minister Mandaviya advised the delegation to focus on the quality of medicines, assuring them that the government is committed to ensuring the highest standards.

Importance of Quality Over Industrial Concerns

He urged the industry representatives not to worry excessively about industrial concerns but to prioritize the quality of pharmaceutical products.

Delegation Satisfaction and Members

Positive Response from Minister

RL Sharma expresses satisfaction with the minister’s response, describing the meeting as a wonderful experience. The minister’s encouragement has instilled confidence in the industry.

Inclusion of General Secretary and Executive Members

The delegation included key members of HPMA, such as the general secretary Vikas Pruthi, and executive members Vineet Gupta and Rohit Gupta, representing a collective and comprehensive industry perspective.

Industry’s Transition Challenges

Impact of RBIs on Production

The RBIs, while essential for maintaining international quality standards, have significantly impacted the production processes of small and medium-scale pharmaceutical manufacturers.

Need for Adequate Time and Support for Compliance

To address these challenges, HPMA emphasizes the necessity of providing adequate time and support for compliance, allowing the industry to meet the required standards without compromising efficiency.

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.

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