Show-cause notices issued to 143 pharma firms after inspections

New Delhi: The Central Drugs Standard Control Organisation along with state licensing authorities has conducted risk-based inspections of 162 pharmaceutical firms and issued show-cause notices in 143 cases, Union Health minister Mansukh Mandaviya said on Tuesday.

In a written reply to a question in Rajya Sabha, he said stop production order has been issued in 40 cases, cancellation and suspension of product/section licenses in 66 cases, issuance of warning letter in 21 cases and in one case, an FIR has been lodged and three persons have been arrested as per the provisions of the Drugs Rules, 1945.

He also said the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry issued a notification on May 22 for amendment in export policy of cough syrups, making it compulsory for cough syrup manufacturers to get certificate of analysis from a government-approved laboratory before exporting their products with effect from June 1.

Accordingly, more than 900 such cough syrup samples have been analysed and Certificate of Analysis (CoA) released as on date, Mandaviya said.

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

The regulatory control over the manufacture, sale and distribution of drug in the country is exercised through a system of licensing and inspection by the State Licensing Authorities (SLAs) appointed by the respective state governments.

Manufacturers are required to comply with the conditions of Licence granted under the said Act and Rules to manufacture any drugs for sale and distribution in the country, Mandaviya said.

When cases concerning quality or safety of drugs are reported, the matter is taken up with the State Licensing Authority (SLA) in order to take necessary action.

The SLAs are legally empowered to take action of violation of any conditions of such licenses, including prosecution in appropriate court of law, he said.

Related Posts

  • Pharma
  • April 24, 2024
  • 44 views
Nepal Drugs Regulator To Conduct On-Site Testing Of Medicines

Kathmandu: In a bid to ensure the quality of medicines being prescribed to patients, the Department of Drug Administration (DDA) has been preparing to carry out on-site tests of medicines. For…

  • Pharma
  • April 23, 2024
  • 31 views
‘Auric’ Relied On Amazon Reviews For Research Claims To Cure Fatty Liver

Ranchi : Patanjali’s case is going on in the Supreme Court for misleading people by showing misleading advertisements. But there are many other pharmaceutical companies in this category. In fact,…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Nepal Drugs Regulator To Conduct On-Site Testing Of Medicines

Nepal Drugs Regulator To Conduct On-Site Testing Of Medicines

‘Auric’ Relied On Amazon Reviews For Research Claims To Cure Fatty Liver

‘Auric’ Relied On Amazon Reviews For Research Claims To Cure Fatty Liver

Misleading Ads Case: Patanjali Issues Public Apology In A Daily Newspaper

Misleading Ads Case: Patanjali Issues Public Apology In A Daily Newspaper

AFMS Collaborates With IIT Delhi To Develop Medical Devices

AFMS Collaborates With IIT Delhi To Develop Medical Devices

Ayush Ministry Told To Act Against Firm Selling Medicine Named ‘Insulin’

Ayush Ministry Told To Act Against Firm Selling Medicine Named ‘Insulin’

2 Youths Arrested With 44770 Pregabalin Capsules

2 Youths Arrested With 44770 Pregabalin Capsules