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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