Guidance Document for Issuance of NOC for Manufacture of Unapproved/ Approved New Drugs for Export Purpose
A manufacturer with a valid license can obtain a No Objection Certificate (NOC) from CDSCO zonal offices for export of unapproved and approved new drugs from India. This procedure applies to unapproved and approved new drugs, excluding narcotic drugs, psychotropic substances, and banned drugs.
CDSCO Seeks Feedback on Draft Guidelines for Similar Biologics in India, 2025
The draft guidelines aim to provide a clear regulatory pathway for manufacturers seeking marketing authorization for similar biologics in India. According to the CDSCO, these guidelines emphasize a comprehensive stepwise approach to demonstrate similarity between a proposed similar biologic product and its reference biological product (RBP).
CDSCO Updates Public Relations Office Hours to Better Serve Stakeholders
The CDSCO’s PRO will now be open to the public from 4:00 PM to 6:00 PM every day, excluding holidays. This adjustment in the schedule is intended to provide a consistent and dedicated timeframe for stakeholders to interact with CDSCO officials and seek clarification on regulatory matters.
CDSCO Enhances Online Portals with Tooltips for Streamlined Application Submissions
These tooltips function as interactive help aids, providing specific instructions and clarifications for each data field. By hovering the cursor over the designated information icon or help text adjacent to a field, users can access concise explanations of the expected input, formatting requirements, and any supporting documentation needed.
Central Government Restricts Use of Common Cold Drug Combination in Children Under Four
The Central Government has now mandated that all manufacturers of fixed-dose combinations of Chlorpheniramine Maleate and Phenylephrine Hydrochloride must clearly and prominently mention the warning “fixed dose combination shall not be used in children below four years of age” on the label, package insert, and any promotional literature associated with the drug.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For March 2025
The NSQ drug list specifies a total of 61 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. The NSQ drug list for central CDSCO laboratories specifies a total of 70 drugs that were detected to be deficient. Additionally, CDSCO has also identified 1 drug to be spurious.
CDSCO Introduces Auto-Generated Market Standing and Non-Conviction Certificates for Medical Devices
To facilitate the transition to the new automated system, the CDSCO has announced that all MSC and NCC applications currently in the old workflow will be automatically rejected by the system. The CDSCO has issued a request to all concerned stakeholders to re-submit fresh MSC and NCC applications through the upgraded online system. This ensures that all applications are processed under the new automated workflow.
Government Tightens Rules for Transfer of SEZ-Manufactured Drugs to Domestic Market
These measures are designed to strengthen oversight of drugs moving from SEZs to the domestic market, safeguarding public health by ensuring that all drugs sold in India meet the required quality, safety, and efficacy standards. This will prevent potentially substandard or unregulated drugs from entering the domestic supply chain.
Government Tightens Quality Control on Drugs
The Indian government has reinforced its commitment to ensuring the quality and safety of drugs available in the market through stringent quality checks, a robust recall system, and enhanced online monitoring. Drugs Inspectors conduct random quality checks by drawing samples from the drug supply chain and CDSCO maintains a “Drug Alert” system on its website
Government Bans Chloramphenicol and Nitrofurans in Food-Producing Animals
The Indian government, through the Central Drugs Standard Control Organization (Veterinary Division), has issued a notification prohibiting the import, manufacture, sale, distribution, and use of drug formulations containing Chloramphenicol or Nitrofurans in any food-producing animal rearing system. This ban, effective immediately, comes in response to concerns about potential risks to human health. This notice was issued on April 2, 2025.
