Manufacture of vaccines in India
Aakarsh Nashier, Associate and Pallavi Puri, Partner at J Sagar Associates expound on India’s regulatory framework for the…
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Regulations/Policies
Govt to announce regulatory guidelines for OTC drugs: Dy Drug Controller, MoH&FW
The consultative committee will give its recommendations to the DTAB, which will be submitted to the government to amend the rules…
CDSCO asks industry to submit suggestions on doping drug labels
The Drugs Technical Advisory Board will be reviewing the matter and preparing draft guidelines
Industry recommends changes in draft guidelines for discontinuation of scheduled formulations
Seek amendments in para 3 and Para 19 to the DPCO 2013
Punjab FDA restricts sale of bulk packs of products with high alcohol content
Valid NOC holders from the fire department and the Punjab Pollution Control Board need to submit a self-attested copy to State FDA…
Centre clarifies reasons for delay in approvals for remdesivir
Informs that it is awaiting data on some crucial parameters from companies that have applied for manufacturing and marketing…
Industry welcomes draft New Drugs and Clinical Trials (Amendment) Rules
Recommend measures for more clarity and impact
Telangana DCA issues approx 110 licenses for manufacturing hand sanitisers
Approves only those based on CDSCO-approved compositions
Ministry of Health publishes draft New Drugs and Clinical Trials (Amendment) Rules
The move is aimed at facilitating the availability of new drugs which are in Phase-III clinical trials (human trials) for…
DoP issues brief guidelines for bulk drug parks, a detailed one to follow
It has also announced the details of a financial assistance programme, including grant-in-aid to three bulk drug parks with a…