Government News

CDSCO to update on a daily basis about batches of cough syrup samples received at each of the central or state drug laboratories. This is to enable work distribution amongst the lab and for release of test reports in a time bound manner by these laboratories.

There is an ongoing global threat posed by toxic cough syrups, the World Health Organization (WHO) told Reuters. The WHO issued safety alerts last year for Indian-made products found in Gambia and Uzbekistan, and this year in Micronesia and the Marshall Islands.

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).

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."

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.

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.

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

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.

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.