India-wide Inspections of Pharma Firms Exposed Major Lapses in Drug Manufacturing, Shows Govt Analysis

Nov 23,2023

Substandard medicines, insufficient training, lack of quality culture, data integrity and more – an internal assessment of Indian pharmaceutical companies has exposed significant lapses during inspections across India.

According to a presentation by Chandrashekhar Ranga, Deputy Drugs Controller, CDSCO, at a session organised by All India Drugs Control Officers’ Confederation (AIDCOC), one of the outcomes of risk-based inspections in 2022-23 was “regulators came to know the ground reality”.

The live webinar session was organised on the topic of ‘Risk Based Inspections in India – An Overview’ on November 18, where Ranga was the speaker. The presentation, accessed by News18, said that the “ultimate objective” of these inspections was to “improve the quality of drugs produced in the country”.

The presentation, under the section on outcomes of Risk-Based Inspections 2022-23, mentions “high NSQ rate”, which means a high rate of non-standard quality products.

It also said the procedure helped in the “convergence of thoughts of the central and state regulators” along with “sensitisation of the manufacturers through outreach programs” and “stress on digitisation”.

The presentation mentioned that the complaints highlighted by Gambia were one of the triggers behind the country-wide launch of inspections.

The Ministry of Health and Family Welfare via its drug regulatory wing, Central Drugs Standard Control Organisation (CDSCO), has been conducting inspections at certain shortlisted companies. These are called risk-based inspections and were triggered after the World Health Organization and several other countries, including Gambia, Uzbekistan, Marshall Islands and Micronesia and the US, raised doubts over the quality of Indian medicines.

The ministry shortlisted ‘risky manufacturing sites’ to conduct inspections in three phases, starting December 2022.

Source: News18