homehealthcare NewsHealth Ministry highlights steps taken to ensure cough syrup and drug quality in India

Health Ministry highlights steps taken to ensure cough syrup and drug quality in India

The Government of India highlighted its efforts to uphold drug quality, particularly for cough syrups, during a Rajya Sabha session. Measures include stringent penalties, joint inspections and expert coordination.

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By Ayushi Agarwal  Aug 9, 2023 5:29:09 PM IST (Published)

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Health Ministry highlights steps taken to ensure cough syrup and drug quality in India
The Rajya Sabha on Wednesday, August 8, witnessed two written responses highlighting the steps taken by the Indian government to ensure that the quality of drugs, especially cough syrups, in the nation is maintained.

In his response, Minister of State for Chemicals and Fertilisers Bhagwanth Khuba pointed at provisions under the Drugs and Cosmetics (Amendment) Act, 2008 which lay out regulatory measures to ensure the quality of medicines in India. These include:
#
Stringent penalties for manufacturers of spurious and adulterated drugs
# Cognisable and non-bailable offences
Special courts in states and Union Territories for the trial of offences under the acts for speedy disposal
Required submission of bioequivalence study results along with applications for manufacturing licenses of oral dosage form drugs
Mandatory joint inspection of manufacturing establishments by the Drugs Inspectors of the Central Government and State Government
Required submission of evidence of stability and safety of excipients to the State Licensing Authority before being granted a manufacturing license by the authority
Increased number of sanctioned posts in the Central Drugs Standard Control Organisation (CDSCO) in the last 10 years
Expert advice and activity coordination by the CDSCO, State Drug Control Organisations, Drugs Consultive Committee, and State Drug Controllers
Furthermore, Health Minister Mansukh Mandaviya wrote specifically about cough syrups and regulatory measures by the administration to ensure their quality. He noted that manufacturers are required to comply with the conditions of the licence granted under the Drugs and Cosmetics Act to manufacture any drugs for sale and distribution in India
In numbers, these are the updates Mandaviya provided:
Action takenNumber of instances
Risk-based inspections162
Show cause notices143
Stop production order40
Cancellation and suspension of product/section licenses66
Warning letters21
FIR lodged1
Persons arrested3
Cough syrup samples analysed900+
Mandaviya also pointed out that the Ministry of Commerce and Industry on May 22 issued a notification mandating cough syrup manufacturers to get a certificate of analysis from a government-approved laboratory before exporting their products.

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