CDSCO Tightens Rules for Export NOCs of New Drugs
Summary: CDSCO released new export NOC guidelines for approved and unapproved medicines. Some of the highlights include a one-year ban on falsified documents, disposal guidelines for outdated stocks, and a two-stage process for application for NOC with improved features. The amendments intend to improve regulatory compliance and safety in exports of drugs.
Stricter Drug Export Rules from CDSCO: What You Must Know
Export of new or unapproved drugs from India is also more regulated now. The Central Drugs Standard Control Organisation (CDSCO) has issued new guidelines for the procedure of obtaining No Objection Certificates (NOCs). The new policy will include approved and unapproved new drugs manufactured domestically for export purposes only.
If you are a drug company looking to export from India, the following is what you should know about compliance, documentation, and shelf-life protocol.
One-Year Ban for Falsified Documents
As a step towards restricting non-adherence, the CDSCO has suggested an excessive fine for the filing of forged documents.
If a candidate submits false documents, the NOC will be cancelled forthwith, and the candidate will be excluded from applying for export NOCs for any item for one year.
This includes both API and formulation manufacturers and constitutes part of the legal obligations that accompany the guidance.
Expired Drugs? Dispose of Them Formally
The order requires the disposal of near-expiration or expired inventory of medicines under formal supervision. Below is how it is categorised:
For Formulations
- The stock that has not been exported may be utilised only if it contains more than 60% of its shelf life.
- If less than 60%, it must be destroyed in the presence of the State Licensing Authority
For APIs (Active Pharmaceutical Ingredients)
- Applying use is permissible only if 3 months’ shelf life is still present.
- Otherwise, destruction is mandatory, supervised by licensing bodies.
Who May Apply for an Export NOC?
Valid license holders in Form 25, Form 28, or Form 28D, i.e., loan licenses, are eligible. NOC will be only for export purposes and not for domestic sales.
Simplified NOC Process: Two-Step Application
The CDSCO has streamlined the NOC process into two varying steps:
Step I: Registration
- Register online once with the zonal office using the Integrated Registration Form (IRF).
- The zonal offices will check the application.
- NOC can be released within 7 working days, having a one-year validity for cleared products.
Step II: Release of Consignment
- On approval of the NOC, reconcile details in a given format.
- Append all documents of support and seek port clearance for every consignment.
- The reconciliation module will remain open within the validity period of the NOC.
No Longer Purchase Order–Specific NOCs (Except for Exceptions)
The previous requirement of possessing PO-specific or quantity-specific NOCs has been waived, except for NDPS (Narcotic Drugs and Psychotropic Substances) and prohibited drugs.
In these cases, a distinct NOC will still be needed per consignment or order.
Checklist of Documents Required
The following are to be filed by applicants to obtain an NOC:
- Online IRF
- Legal undertaking
- Copy of manufacturing license
- Reconciliation data
- NRA (National Regulatory Authority) import approval of the importing country
Without NRA clearance, other options are based on whether the product is:
- API or formulation
- Approved or unapproved in India
- Maybe for R&D or under NCE studies
Special Rules for NDPS and Banned Drugs
Exporting NDPS or banned drugs? The old rules still apply:
- You’ll require a quantity-specific and PO-specific NOC for every shipment.
Conclusion: Stronger Compliance, Safer Exports
The new CDSCO regulation promotes more transparency, enhanced compliance, and higher safety for Indian exports of medicines.
Now the manufacturers have to adhere to tougher documentation standards, shelf life, and licensing. The one-year ban on the practice of presenting fictitious documents is a big leap towards responsibility.
The amendments align with the international standards of drug exports, enhancing India’s credibility as a good supplier in the international pharmacy business.
Inputs from various media sources.
Dane
I am an MBBS graduate and a dedicated medical writer with a strong passion for deep research and psychology. I enjoy breaking down complex medical topics into engaging, easy-to-understand content, aiming to educate and inspire readers by exploring the fascinating connection between health, science, and the human mind.
