Good Manufacturing Practice (GMP) is a systematic approach to ensuring that pharmaceutical products are manufactured consistently and controlled to meet established quality standards. GMP encompasses various aspects of production, including the quality of materials, manufacturing methods, machinery, facilities, and personnel involved in the process.
Compliance with GMP is crucial for ensuring the safety, efficacy, and quality of medicines. It fosters trust in pharmaceutical products among consumers and is essential for both domestic markets and international exports.
Schedule M specifies the standards for GMP compliance in India. The revised version aligns Indian standards with the World Health Organization (WHO) guidelines, enhancing the global competitiveness of Indian pharmaceuticals.
The government has extended the deadline for micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector to meet the revised Schedule M standards until 31 December 2025. The enforcement of these new rules will begin on 1 January 2026.
Industry associations requested an extension to provide MSMEs with adequate time to improve their facilities and processes, citing various financial and technical challenges.
Large pharmaceutical manufacturers with revenues exceeding ₹250 crore will have a shorter transition period of just six months to comply with the revised GMP standards.
Out of approximately 10,500 pharmaceutical manufacturing units in India, only around 2,000 MSMEs have achieved GMP certification, indicating that approximately 8,500 units still need to comply.
The government, along with the Central Drugs Standard Control Organization (CDSCO), is implementing several initiatives to support MSMEs:
The CDSCO is responsible for inspecting manufacturing units, collaborating with state and union territory authorities, and monitoring the progress of GMP compliance within the pharmaceutical sector.
India is a prominent exporter of medicines to developing nations. Achieving WHO GMP certification is vital for strengthening India’s position in the global market, ensuring adherence to international quality standards.
Q1. What does GMP stand for?
Answer: GMP stands for Good Manufacturing Practice, which is a system of guidelines that ensures pharmaceutical products are manufactured to quality standards consistently.
Q2. What is Schedule M?
Answer: Schedule M specifies the manufacturing standards for GMP compliance in India, which have been revised to align with WHO guidelines.
Q3. When is the new GMP compliance deadline for MSMEs?
Answer: The new deadline for MSMEs to comply with revised Schedule M is 31 December 2025, with enforcement starting on 1 January 2026.
Q4. Why is GMP compliance important for exports?
Answer: GMP compliance is crucial for ensuring the quality and safety of medicines, which helps build trust and facilitates exports to international markets.
Q5. How many MSMEs are GMP-certified in India?
Answer: Currently, about 2,000 out of 10,500 pharmaceutical manufacturing units in India are GMP-certified.
Question 1: What does GMP ensure in pharmaceutical manufacturing?
A) Quality standards are met
B) Cost reduction
C) Market expansion
D) None of the above
Correct Answer: A
Question 2: What is the extended deadline for MSMEs to comply with GMP regulations?
A) 30 June 2025
B) 31 December 2025
C) 1 January 2026
D) 31 March 2026
Correct Answer: B
Question 3: Which organization is responsible for GMP compliance in India?
A) WHO
B) CDSCO
C) MSME Ministry
D) FSSAI
Correct Answer: B
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