Ingredients News - CDSCO begins joint inspections with state drug controllers of Sch M units across country


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CDSCO begins joint inspections with state drug controllers of Sch M units across country

Shardul Nautiyal, Mumbai January 10 , 2018

The Central Drugs Standard Control Organisation (CDSCO) and state drug controllers have started conducting joint inspections of manufacturing facilities across the country to check the compliance levels of Schedule M as per GMP norms.

Joint inspections are aimed at streamlining uniform inspection procedures across the country related to GMP. The inspections have been closely followed with the responses drawn from the concerned manufacturers based on the checklist issued for self audit meant to assess adherence to the licensing conditions as envisaged in the Drugs and Cosmetics Act.

Drug Controller General of India Dr G N Singh said, “The joint inspections have been started and will be helpful in assessing compliance levels of the concerned manufacturers.”

The CDSCO has also been conducting risk based inspections across the country to verify GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945. It has till date concluded 185 risk based inspections in 8 phases.

These risk based inspections are 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.

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.

Meanwhile, Maharashtra FDA is in the process of verifying compliance reports of self -audits done by around 800 manufacturers in the state.

Maharashtra FDA canceled 36 manufacturing licenses and suspended another 90 after serving 136 show cause notices (SCN) for non-compliance of D&C Rules last year. The state regulator had conducted 837 inspections over the past 6 months for the period from April 2017 to October 2017.

CDSCO has also recently proposed towards making stability tests compulsory for all drugs, including active pharmaceutical ingredients (APIs). An advisory letter has already been sent to the state drug controllers and a notification amending the rules is likely to come soon, according to a senior CDSCO official.

Once the rules take effect, pharma companies will have to subject their products to quality tests to make sure that drugs do not lose their potency and the expiry dates printed on the packaging are based on the test results.

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