Revised GMP guidelines for Pharma in India

Biopharma

The Indian government has recently mandated all pharmaceutical companies to adopt the updated Good Manufacturing Practices (GMP) to bring their operations in line with global standards. Larger companies, with a turnover exceeding Rs. 250 crores, are required to implement these changes within six months. Meanwhile, medium and small-scale businesses, with a turnover of less than Rs. 250 crores, must comply within one year.

Why are Improved Standards Necessary?

The revised manufacturing guidelines introduce several key changes, including:

1. The introduction of a comprehensive pharmaceutical quality system.
2. The inclusion of quality risk management and product quality reviews.
3. Mandatory validation of equipment and the establishment of a change control system to assess any modifications that could affect production or product quality.

Under the new rules, companies must ensure that drugs are stored in a stability chamber with the correct temperature and humidity levels and must conduct accelerated stability testing.

The guidelines also emphasize the need for GMP-compliant computerized systems to prevent data tampering. These systems will prevent unauthorized access and alterations to data, with backup provisions to safeguard against data loss.

Moreover, the updated Schedule M outlines additional requirements for products like biological products, agents containing radioactive ingredients, or plant-derived products. It also covers the manufacturing of investigational products for clinical trials.

These revisions aim to ensure pharmaceutical companies adhere to standardized processes, maintain stringent quality control measures, and avoid shortcuts. This will improve the quality of medicines produced in India and those sold globally.

How Will These Changes Benefit the Industry?

1. Establishing uniform quality standards across the pharmaceutical industry.
2. Enhancing the quality of drugs available in the domestic market.
3. Enabling the government to ensure that all manufacturing units comply with global standards.
4. Reducing the need for repeated inspections by multiple regulatory authorities.
5. Positioning India as a global hub for high-quality pharmaceuticals.

Timeline for Implementation

The changes are set to be implemented from August 1, as announced by the Union Health Minister. Larger companies have six months to implement the changes, while smaller companies are given one year. However, the new Schedule M has not yet been officially notified, according to experts.

A drug manufacturer commented, “When the draft guidelines were first released, the industry felt that at least 36 months would be necessary for making the required adjustments. The one-year deadline may be extended. Smaller companies face the challenge of making significant changes, while most larger Indian companies already adhere to global GMP standards.”

To assist smaller companies, the Department of Pharmaceuticals has introduced a scheme offering credit-linked capital and interest subsidies for the modernization of MSME units.ls also has a scheme to provide credit-linked capital and interest subsidy for upgradation of MSME units.