DCGI Announces Permanent Integration of Risk-Based Inspections in Pharmaceutical Units

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Rajeev Raghuvanshi, the Drug Controller General of India (DCGI), informed that implementing risk-based inspections in pharmaceutical manufacturing units and private testing laboratories will become a permanent fixture to uphold the highest standards and safety protocols in the industry. He stated that these inspections, initiated in February, will now be a consistent practice.

Raghuvanshi highlighted the regulatory measures enacted by the government following incidents related to cough syrup, which has shaken the confidence among international buyers. He stressed that there has been no significant issues in the past eight months, indicating a positive trend.

He mentioned that since July 2023, approximately 4,500 export batches have undergone testing, with none failing. He also updated about the control measures undertaken by the DCGI, especially concerning cough syrups and their supply chains during the winter months.

Regarding regulatory standards, Raghuvanshi highlighted the importance of the revised Schedule M, which aligns Indian pharmaceutical standards with those of the World Health Organization (WHO). This update will enhance the competitiveness of the Indian pharmaceutical industry globally and stimulate exports. As reported by The Times of India, in terms of testing facilities, Raghuvanshi mentioned that there are currently eight laboratories, with two more in development and a couple more expected within the year.

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