Pharma Industry under scrutiny: Key regulatory steps by CDSCO and State Authorities

Last Updated on October 6, 2024 by The Health Master

Regulatory Steps by CDSCO and State Authorities

The Central Drugs Standard Control Organisation (CDSCO) and state licensing authorities have recently concluded risk-based inspections of 162 pharmaceutical companies, leading to significant regulatory actions.

Union Health Minister Mansukh Mandaviya provided comprehensive insights into the outcomes of these inspections in a statement made in the Rajya Sabha.

Regulatory Inspections and Actions

According to Minister Mansukh Mandaviya, the joint efforts of CDSCO and state licensing authorities have yielded impactful results:

Show Cause Notices Issued:

A total of 143 pharmaceutical companies have received show cause notices as a result of the inspections, indicating potential violations of regulatory standards.

Stop Production Orders:

In 40 cases, a stop production order has been enforced, temporarily halting the manufacturing processes due to identified compliance issues.

License Cancellation and Suspension:

Regulatory authorities have suspended or canceled product/section licenses in 66 cases, reflecting serious concerns about compliance with drug regulations.

Warning Letters:

In 21 instances, warning letters have been issued to pharmaceutical companies, highlighting areas where adherence to regulatory standards is needed.

Legal Action:

One case stands out where an FIR (First Information Report) has been lodged, leading to the arrest of three individuals. This action was taken in accordance with the provisions of the Drugs Rules, 1945.

Amendment in Export Policy for Cough Syrups

Minister Mandaviya highlighted an important development regarding the export of cough syrups:

Policy Amendment:

The Directorate General of Foreign Trade (DGFT), under the Department of Commerce, Ministry of Commerce and Industry, issued a notification on May 22, 2023.

This notification mandates cough syrup manufacturers to obtain a certificate of analysis from a government-approved laboratory before exporting their products.

The amendment came into effect on June 1, 2023.

Analysis and Certification:

In response to this policy amendment, more than 900 cough syrup samples have been meticulously analyzed.

As of the current date, corresponding Certificates of Analysis (CoA) have been released, ensuring compliance with the newly enforced requirements.

Regulation of Drug Industry

Mansukh Mandaviya further elaborated on the regulatory framework governing the pharmaceutical industry:

Drugs and Cosmetics Act, 1940:

The manufacturing, sale, and distribution of drugs in India are regulated under the provisions of the Drugs and Cosmetics Act, 1940, along with the accompanying Rules of 1945.

Licensing and Inspection:

Regulatory oversight encompasses a licensing and inspection system administered by State Licensing Authorities (SLAs) appointed by respective state governments.

Manufacturers are obligated to adhere to the terms and conditions of the licenses granted under the Act and Rules when producing drugs for sale and distribution.

Quality and Safety Concerns:

Instances of reported concerns about drug quality and safety trigger responses from regulatory bodies.

The State Licensing Authority (SLA) takes the lead in initiating necessary actions when such cases are reported.

Empowered Actions:

SLAs have legal authority to undertake actions against violations of license conditions, including the option of prosecution in appropriate courts of law.

In conclusion, the proactive collaboration between the Central Drugs Standard Control Organisation and state licensing authorities underscores the commitment to upholding pharmaceutical industry standards and ensuring the safety and quality of drugs available in the market.

The recent policy amendment related to cough syrup exports also showcases the government’s dedication to enhancing oversight and maintaining transparency within the pharmaceutical sector.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.

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