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DCGI to audit mfg sites of cos before giving approvals for new drugs

Shardul Nautiyal, Mumbai
Monday, July 31, 2017, 08:00 Hrs  [IST]

Drug Controller General of India (DCGI) has 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.

This is a major policy shift as earlier Central Drugs Standard Control Organisation (CDSCO) inspections were not carried out at manufacturing sites before giving approval for a new drug in the country.

Generally, health ministry constituted Subject Experts Committee (SEC), Technical Committee and Apex Committee examine applications for clinical trials in India before giving approval to the new drug. All of the studies are approved by the DCGI before the final approval.

“Since we are giving relaxation in clinical trials on a case-to-case basis, the preparedness for manufacturing high quality medicines to be made available to the Indian population need to be assured at the manufacturing facility. This will happen when we have a robust system of auditing, engaging and knowing the preparedness of the manufacturer,“ explains Drug Controller General of India Dr G N Singh.  

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.

He further adds, “These audits are also required in cases where clinical trial waiver is given to the manufacturer for a particular new drug or there is serious doubt about quality of the drug based on surveillance. Meanwhile, risk based audits are also going on to ensure patient safety by verification at the point of production.”

CDSCO has, till date, successfully concluded 185 risk based inspections in 8 phases 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 aimed at streamlining uniform inspection procedures across the country related to good manufacturing practices (GMP). The checklist and tool is meant to help CDSCO and state drug regulators 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.

CDSCO has developed checklist and evaluation tool to outline proper inspection procedures with a consistent nationwide approach for the inspections to be carried out by CDSCO officials and state regulators.

Specifications mentioned in the checklist include specify whether the whole facility is separated, dedicated and is not a part of any other non-drug facility, specify whether the surroundings of manufacturing area is clean and as per the SOP prescribed in this regard. (Mention the SOP nos.), describe the pest, insects, birds and rodents control system followed in the premises. Specify pest control schedule- area wise, along with materials and methods used and specify the level maintained in various parts of the premise (storage area, manufacturing area specially visual inspection, laboratory areas etc).


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