The Importance of Good Manufacturing Practices in Pharmaceuticals

GOOD MANUFACTURING PRACTICES (GMP) IN THE PHARMA INDUSTRY

(GS Paper III – Indian Economy, Science and Technology, Public Health)

FUNDAMENTALS

Good Manufacturing Practices (GMP) are a set of internationally recognized guidelines that ensure pharmaceutical products are consistently produced and controlled according to quality standards. They cover every stage of the production process — from sourcing raw materials to packaging — ensuring the safety, purity, and effectiveness of medicines.

India follows Schedule M of the Drugs and Cosmetics Act, 1940, which aligns with WHO-GMP norms. From December 31, 2025, small and medium drug manufacturers (with a turnover below ₹250 crore) must comply with these updated GMP standards.

EXAMPLES AND EXPLANATION

1. Raw Material Control:
Firms must verify the quality and authenticity of raw materials before use.
Example: A company producing cough syrup must test glycerin for contaminants like diethylene glycol (DEG) to avoid poisoning incidents.

2. Production Process Documentation:
Every stage of manufacturing must be recorded and traceable.
Example: If an antibiotic batch is found defective, GMP records help identify where and how the fault occurred.

3. Sanitation and Hygiene:
Facilities must maintain cleanliness to prevent microbial contamination.
Example: Workers must wear sterile clothing and operate in clean rooms when producing injectables.

4. Quality Control and Testing:
Random samples from each batch must be tested before approval.
Example: A tablet manufacturer must ensure that the active ingredient concentration remains within the specified limits.

5. Storage and Distribution:
Medicines must be stored under prescribed temperature and humidity levels.
Example: Vaccines requiring cold chains must never be stored above the recommended temperature range.

6. Staff Training:
All employees must understand and follow quality protocols.
Example: Staff handling packaging machines must be trained to prevent labeling mix-ups.

WHY IT MATTERS

• Ensures drug safety and builds public trust.
• Prevents export rejections from regulated markets like the EU and USA.
• Minimises tragedies such as the 2023 Gambia cough syrup deaths caused by contaminated exports.
• Supports India’s goal to become a global pharmacy hub under the “Make in India” initiative.

CHALLENGES

• High compliance costs for facility upgrades, especially for small firms.
• Limited availability of trained personnel for documentation and quality control.
• Some manufacturers may surrender licences due to financial strain.

GOVERNMENT SUPPORT

The Health Ministry has launched the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) to provide financial aid for technology upgrades and GMP compliance. Regular inspections by the Central Drugs Standard Control Organisation (CDSCO) are conducted to ensure adherence to quality standards.

SYNOPSIS (75 WORDS)

Good Manufacturing Practices (GMP) are vital for producing safe, high-quality drugs. India’s revised Schedule M norms, effective from December 31, 2025, will enforce stricter quality controls among small and medium pharmaceutical firms. These standards focus on raw material testing, hygiene, documentation, and staff training. Though compliance costs may rise, these reforms strengthen public safety, global export credibility, and India’s leadership as the “pharmacy of the world.”