https://shabas.net/

U.S.-based consulting firm providing compliance and remediation expertise in scientific, technical, regulatory affairs, and management to public and private sector organizations.

 

Indian Govt sets deadline for Pharma GMP Compliance

Adopt WHO-standard good manufacturing practices (GMP) within One Year

The Indian government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) compliant with World Health Organization (WHO) standards for all Indian pharmaceutical manufacturers.

The Central Drugs Standard Control Organization (CDSCO), India’s national regulatory body for cosmetics, pharmaceuticals, and medical devices, has set a variable deadline for mandatory implementation of the Good Manufacturing Practices (GMP) in India pharmaceutical industries dependent upon company size (sales volume).

This was after the incidents of several countries reporting deaths allegedly linked to contaminated India-manufactured drugs.

WHO GMP compliance Timeline

Drug Manufacturer Size	Criterion	GMP Deadline
Large Manufacturers	sales turnover > Rs 250 crore (~ $30 million sales):	within six months.
Med/small Manufacturers	< Rs 250 crore (< $30 million sales):	within a year

 

Penalty for non-compliance by deadline:

Those who do not comply with the direction will face suspension of license and/ or penalty.

Aside from WHO GMP compliance, manufacturers are expected to:

       introduce a GMP-related computerized system.

       carry out stability studies as per local climate conditions.

Exports already have to be WHO-GMP certified.

Domestic market permitted if they meet Schedule M of rules India Drugs and Cosmetics Act., including specifications of the manufacturing units, processes that need to be followed, and equipment needed.

Deficiencies noted during numerous Risk-based inspection drug manufacturers included:

       absence of testing of raw materials before use,

       absence of quality failure investigation of its products,

       faulty design of manufacturing and testing areas.

Indian regulators noted that at a minimum, all Indian drug manufacturers (both domestic and global suppliers) will be required to implement improvements and ensure compliance with GMP basic processes and standards:

       Adoption of a pharmaceutical quality system,

       quality risk management,

       product quality review, and

       validation of equipment.

Final Note:

U.S. FDA and EU are launching the Quality Management Maturity (QMM) initiative to combat the serious problem of therapeutic drug shortages worldwide. Indias GMP compliance issues and other global companies and regions can effectively be ameliorated by participating in the QMM program.

 

Bibliography / References

       Dutt, A., Adopt WHO-standard good manufacturing practices- Govt sets deadline for pharma, Indian Express (03Aug2023) https://vajiramandravi.s3.us-east-1.amazonaws.com/media/2023/8/3/10/17/49/Adopt_WHO-standard_good_manufacturing_practices.pdf

       Das, S. A Case of Slipping Quality, Biospectrum India, (01Aug2023) https://www.biospectrumindia.com/features/73/23368/a-case-of-slipping-quality-.html

       Perappadan, B, Health Ministry sets deadline for pharma industry to implement revised Schedule M, The Hindu News, https://www.thehindu.com/news/national/health-ministry-sets-deadline-for-pharma-industry-to-implement-revised-schedule-m/article67150520.ece (01Aug2023)

       World Health Organization (WHO), Good Manufacturing Practice Guidelines (GMP)

o   WHO Health products policy and standards https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp

o   WHO Pharmaceutical Production, https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines/production

o   WHO good manufacturing practices for sterile pharmaceutical products, https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/production/trs1044-annex-2-gmp-for-sterile-pharmaceutical-products.pdf?sfvrsn=d924ed65_1&download=true

o   Annex 2 – Guidelines for Biological Products, https://cdn.who.int/media/docs/default-source/biologicals/gmp/annex-2-who-good-manufacturing-practices-for-biological-products.pdf?sfvrsn=995d5518_2&download=true