Government News

Government has banned 14 FDCs which has no therapeutics justification

Rajesh Vagh Mon, 06/05/2023 - 16:13

Government has banned 14 FDCs after recommendations of the Expert Committee which stated that there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings.

The Central Government in exercise of the powers conferred by section 26A of the Drugs and Cosmetics act 1940 (23 of 1940) prohibited the manufacture for sale, sale and distribution for human use of 14 drug FDCs (fixed dose combinations).

DCA shuts 11 pharma companies in Himachal Pradesh

Rajesh Vagh Fri, 05/26/2023 - 15:58

The Drug Control Administration (DCA) has stopped 11 pharmaceutical manufacturing firms located in the pharmaceutical hub of Baddi, Barotiwala, Nalagarh, Sirmaur and Kangra districts after significant observations were detected in its functioning during risk-based inspections conducted recently.

State Drugs Controller Navneet Marwaha said, "In the last two months, 29 firms were inspected in the second phase of the joint inspection by the state DCA and the Central Drugs Standard Control Organisation."

Cough syrup testing at government labs mandatory before export

Rajesh Vagh Tue, 05/23/2023 - 17:03

The Director General of foreign Trade made an amendment in the export policy of cough syrup. Now, it is required to test export samples from government labs before exporting cough syrup.

As per revised export policy, cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis issued by government laboratories.

17 May 2023

Now CROs require authorisation from Central Licencing Authority

As per new amendment of New Drugs and Clinical Trials, Clinical Research Organisations cannot conduct any clinical trial or bioavailability studies without permission from Central Licencing Authority.

As per new amendment, application for registration of Clinical Research Organisation for the purpose of conducting clinical trial or bioavailability or bioequivalence study with the Central Licencing Authority shall be made to the said authority in Form CT-07B.

27 April 2023

Cabinet approves the Policy for the Medical Devices Sector

The Union Cabinet, chaired by the Hon'ble Prime Minister Shri Narendra Modi, today approved the National Medical Devices Policy, 2023.

14 April 2023

AIOCD writes DCGI on irregularities by online pharmacy continues

The All India Organisation of Chemists & Druggists (AIOCD) has written to the Drug Controller General of India (DCGI) on operations of online Pharmacies. AIOCD stated that despite the issuance of notices, E-Pharmacy companies have not stopped their operations.

1 April 2023

No Custom duty on import of medicines used in rare diseases, says India

Government has given full exemption from custom duty on import of medicines used in rare diseases. The Central Government has given full exemption from basic customs duty on all drugs and Food for Special Medical Purposes imported for personal use for treatment of all Rare Diseases listed under the National Policy for Rare Diseases 2021 through a general exemption notification.

1 April 2023

Government to set up 270 pharmacies in Eastern Railways

Healthcare facilities such as pharmacies and collection centres for pathology laboratories will be established at 270 stations in the Eastern Railway zone by the end of this year.

“In a bid to spread healthcare facilities to the remotest corner of its network, the Eastern Railway has awarded the contract for setting up healthcare-focused multi-utility stores at 270 stations for a period of five years,” Arora told reporters.

24 March 2023

PCI invites Government faculty for panel empanelment of Exit Exam

Pharmacy council of India is preparing for the exit exam for Diploma pharmacy. PCI invites Government faculty for panel empanelment of Exit Exam.

PCI (Pharmacy council of India) said in a notification that this is to bring to kind information that Exit Examination for Diploma in Pharmacy has to be conducted. Faculty from Government and Government Aided colleges are hereby informed to fill the form for being considered as an expert.

11 March 2023

IPC indicates ADRs associated with Cephalosporins and Amikacin

Indian Pharmacopoeia commission, IPC indicated adverse drug interactions associated with widely used antibiotic cephalosporins and Amikacin.

Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from Gram-positive and Gram-negative bacteria.And Amikacin is indicated in the treatment of serious infections due to amikacin sensitive organisms.

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Now CROs require authorisation from Central Licencing Authority

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