Quick Response code to be affixed with bulk Drug labels
A draft of the Drugs and Cosmetics Rules, 1945 has been published, which mandates a Quick Response code or information readable with software application to be affixed on the label of every pharmaceutical ingredient (bulk drug) manufactured or imported in India.
CDSCO Issues clarification on manufacturing of new drug in multiple manufacturing sites
The Central Drugs Standard Control Organization (CDSCO) through its circular dated 30th August 2019 has issued a clarification on manufacturing of new drug by a manufacturer in its own additional site.
Health Service Personnel and Clinical Establishments (Prohibition of violence and damage to property) – Bill
The Ministry of Health and Family Welfare (MoHFW) on September 02, 2019, has published a Draft Bill on the Health Service Personnel and Clinical Establishments (Prohibition of violence and damage to property) Act, 2019 to prohibit violence against health service personnel and damage or loss to property of clinical establishments.
CDSCO issues advisory on labelling requirements for combi kit of Misoprostol and Mifepristone tablets for MTP
The Central Drugs Standard Control Organisation (“CDSCO”) has, in a letter dated 9th August, 2019, issued an advisory for all the state and union territory drug controller are now directed via this CDSCO letter to ensure the effective implemtitaion of labelling requirement requirements.
The CDSCO has instructed that such Combi Kit must come with the following warning:
“Warning: product is to be used only under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 & MTP Rules 2003.
MoHFW Invites comments on draft of Classification and Categorization of Clinical Establishment
The Ministry of Health and Family Welfare has issued draft rules for Classification and Categorization of Clinical Establishment on July 17, 2019.The clinical establishment under the draft has been defined in a vast way to include every entity or institution administering any medical facility. In addition to the definitions, draft also seeks to provide categories […]
Medical Colleges may be Permitted for Lower Capacity Intake
The Medical Council of India (MCI) on June 25, 2019 has notified the commencement of Establishment of Medical College Regulations (Amendment), 2019, thereby amending the existing Establishment of Medical College Regulations, 1999.
Drugs and Cosmetic (11th amendment)Rules notified
The Drugs and Cosmetic Rules, 1945 has been amended by Drugs and Cosmetics (Eleventh Amendment) Rules, 2019 dated 17th July 2019.
The newly revised rules now require manufacturers and distributors of drugs specified in Schedule C and C (1) to pay a “licence retention fee” for a valid licence. In case of failure to pay, the licensee will be required to pay a late fee calculated at the rate of 2 percent of the licence fee for every month up to six months. In case of non-payment, the licence will be cancelled. The same shall also apply to holders of a loan licence.
The Rules related to renewal has been removed from Rule 150J and 150E. Form 24C and 26J has also been amended.
Kerala Clinical Establishment Act extended to other system of medicines
The Government of Kerala has decided by a notification, that Kerala Clinical Establishments (Registration and Regulation) Act, 2018 shall come into force in respect of the these recognised systems of medicines from 15th June, 2019: Naturopathy Ayurveda Homoeopathy Sidha Unani The Act has come into force from 1st January 2019. Section 1(2) provided power to […]
The National Pharmaceutical Pricing Authority Fixes the Ceiling Price for ‘Ibuprofen’
The National Pharmaceutical Pricing Authority (NPPA) set up by the Ministry of Chemicals and Fertilizers issued an order dated June 26, 2019, fixing the Ceiling Price as Rs. 2.62 per capsule for ‘Ibuprofen’ (Schedule Formulation) 200 mg Capsule. Every retailer and dealer shall display a price list on a conspicuous part of the business premises to provide access to any person seeking assistance on it.
West Bengal forms an Audit Committee for Dengue Deaths
Deaths caused by dengue has increased at a rapid rate in Kolkata, In view of the same, an expert Committee is to be set up for conducting audit on deaths caused by Dengue. All health care facilities are notified to cooperate with the audit committee and keep and submit all necessary documents related to deaths caused by dengue.
