In response to Unstarred Question No. †995, Shri Kaushalendra Kumar asked the Minister of Health and Family Welfare about relaxing the time limit for pharmaceutical companies to implement Good Manufacturing Practices (GMP). The Minister of State in the Ministry of Health and Family Welfare, Smt. Anupriya Patel, answered that the Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise Schedule M related to GMP. The revised Schedule M became effective for drug manufacturers with turnover exceeding Rs. 250 crores from 29.06.2024. A conditional extension until 31.12.2025 has been granted to manufacturers with turnover less than Rs. 250 crores who submitted their upgradation plan.
Key Entities Referenced
Good Manufacturing Practices (GMP): Practices related to manufacturing quality pharmaceutical products.
Drugs Rules 1945: Rules related to Good Manufacturing Practices
Ministry of Health and Family Welfare: The central ministry responsible for policies related to health and family welfare.
Schedule M: Schedule to the Drugs Rules 1945 concerning Good Manufacturing Practices (GMP).
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARRED QUESTION NO. †995
TOBE ANSWERED ON05TH DECEMBER, 2025
IMPLEMENTATION OFGOODMANUFACTURING PRACTICES (GMP)
†995.SHRIKAUSHALENDRAKUMAR:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government is considering relaxing the time limit applicable for
pharmaceutical companiestoimplementGood Manufacturing Practices (GMP);
(b)if so, the detailsthereof;
(c) whether several pharmaceutical companies have not been able to implement GMPs yet;
and
(d) if so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(d): Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E)
dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing
Practices and requirements of premises, plant and equipment for pharmaceutical products.
Revised Schedule M has become effective for the drug manufacturers with turnover > Rs.
250croresfrom 29.06.2024.However, for manufacturershavingturnoverof less thanRs. 250
Cr, conditional extension has been granted up to 31.12.2025 for those who submitted their
upgradationplan.
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