394 Product Permissions of 14 banned FDCs to be cancelled: Gujarat

Last Updated on January 6, 2024 by The Health Master

394 Product Permissions of 14 banned FDCs

The Gujarat Food and Drug Control Administration (FDCA) has taken action to cancel 394 product licenses granted to 168 companies in the state.

These licenses were issued for 14 fixed dose combination (FDC) medicines that have been banned.

Among the banned medicines, approximately 40% or 150 of them were also intended for export purposes.

This cancellation accounts for only 0.06% of the total product licenses granted in Gujarat, where over 6.5 lakh product licenses have been issued to 3,533 manufacturers.

Gujarat FDCA Takes Strict Measures Against Banned FDC Medicines

Gujarat FDCA’s Announcement:

Dr H G Koshia, Commissioner of Gujarat FDCA, has stated that manufacturing and selling banned FDC medicines is a criminal offense under the Drug Rules, with provisions for imprisonment and fines.

In order to ensure compliance with the ban on FDC drugs, the Gujarat FDCA has sent bulk SMS alerts to over 51,000 retailers and wholesalers throughout the state.

Related news: Govt prohibits 14 FDC Drugs, Citing Safety Concerns

Immediate Ban on 14 FDC Medicines in Gujarat

Government Gazette Notification:

On June 2, 2023, a Government Gazette Notification was issued, banning 14 FDC medicines with immediate effect.

The decision was based on the recommendation of an expert committee that found no therapeutic justification for these combinations and concluded that they may pose risks to human health.

The notification emphasized the need to prohibit the manufacturing, sale, and distribution of these FDCs in the interest of public safety. The ban aligns with the expert committee’s assessment of the efficacy of these drug combinations.

Banned Combinations and Their Usage:

The banned FDC combinations primarily include over-the-counter (OTC) drugs used for treating cough, fever, and infections.

Fixed dose combinations refer to products that contain one or more active ingredients designed for specific medical indications.

List of Banned FDC Medicines Released by Gujarat FDCA

SMS Alert System for Drug Recall:

The Gujarat FDCA’s SMS alert online system has released a list of drugs that have been banned by the Central Drugs Standard Control Organization (CDSCO), Delhi.

The list, communicated through a Gazette Notification dated June 2, 2023, instructs manufacturers, distributors, and retailers to immediately halt the manufacturing, use, sale, distribution, and recall of the following FDC medicines:

1. Nimesulide, paracetamol dispersible tablet
2. Amoxicillin, bromhexine
3. Pholcodine, promethazine
4. Chlorpheniramine maleate, dextromethorphan, guaiphenesin, ammonium chloride, menthol
5. Ammonium chloride, bromhexine, dextromethorphan
6. Chlorpheniramine maleate, codeine syrup
7. Bromhexine, dextromethorphan, ammonium chloride, menthol
8. Dextromethorphan, chlorpheniramine maleate, guaiphenesin, ammonium chloride
9. Paracetamol, bromhexine, phenylephrine, chlorpheniramine, guaiphenesin
10. Salbutamol, bromhexine
11. Chlorpheniramine, codeine phosphate, menthol syrup
12. Phenytoin, phenobarbitone sodium
13. Ammonium chloride, sodium citrate, chlorpheniramine maleate, menthol syrup
14. Salbutamol, hydroxy ethyl theophylline, bromhexine

Gujarat FDCA’s Online Platform for Licensing:

Since its establishment in 2011, the Gujarat FDCA’s online platform for drug manufacturing license applications (DMLA) has facilitated efficient and paperless services.

This platform enables timely granting of product licenses for active pharmaceutical ingredients (APIs) and formulations in the allopathic segment.

Simplifying Licensing Processes:

In addition to license renewals and applications for additional products, the online system also handles certificates required for exports, such as free sale certificates, no conviction certificates, capacity certificates, general GMP certificates, GLP certificates, and market standing certificates.

The online platform, known as the extended licensing node (XLN) system, has been operational since April 2014 and has streamlined the process of granting certificates and licenses.

It now seamlessly and user-friendlyly manages the issuance of loan licenses, test licenses, certificates, additional products, and renewals for pharmaceutical manufacturing units in Gujarat.

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