With India facing repeated scrutiny of its manufacturing facilities for quality issues, the Central Drugs Standard Control Organisation (CDSCO) is likely to start another phase of risk based inspections across the country to verify good manufacturing practices (GMP) compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945.

These Risk Based inspections will be based on a checklist issued for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country. CDSCO checklist and evaluation is also aimed at streamlining uniform inspection procedures across the country related to GMP.

CDSCO recently concluded 185 risk based inspections in 8 phases based on a checklist issued for the state drug regulators and will soon roll out another phase of risk based inspections based on the need for compliance by all Schedule M units, informed a senior CDSCO official.

The checklist and tool is meant to help CDSCO and state drug regulators to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant. The inspections are planned and carried out jointly by the CDSCO officials and Drug Inspectors of the States concerned.

The Union health ministry is also in the final stages to release a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products.

There are also plans to establish a drug audit office in China for inspection of drug manufacturing units there on a regular basis. The project is, however, waiting for the approval from the several ministries of both the countries.

As per the Drug Controller General of India (DCGI) plan, at least four Indian drug inspectors are supposed to be posted in China to examine manufacturing sites and check that these units are complying with GMPs. The proposed drug audit office in China will be equivalent to the audit office of US FDA and other representative offices of any foreign drug regulatory agency which operates in India and elsewhere.

DCGI has also started auditing manufacturing facilities in the country for stability studies and to verify minimum requirements for product quality assurance before giving final approvals for new drugs.

Basic purpose of the exercise is to conform to the expectation of the regulators, ability to adhere to the needs of science and focus on quality by ensuring that basic standards of quality requirements are met.