Date: 2023-06-21Category: Not ApplicableState: Union GovernmentCountry: India
Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories for testing Request not to submit any sample of cough syrup to CDTL Mumbai Lab
**Summary:**
This policy directive, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, on June 21, 2023, addresses the backlog of cough syrup samples awaiting testing for export clearance. The communication, reference number F.No. DCGIMISC202309, instructs all drug manufacturers and exporters, particularly those in Maharashtra, to temporarily cease submitting cough syrup samples to the Central Drugs Testing Laboratory (CDTL), Mumbai. As of June 21, 2023, CDTL, Mumbai, had 93 cough syrup samples undergoing testing. The directive advises manufacturer-exporters to consult the CDSCO website daily to identify laboratories with available capacity (i.e., those with no or few samples) and submit their samples accordingly. This measure aims to expedite the release of testing reports by optimizing laboratory resource allocation. The policy requests cooperation from manufacturers and exporters to ensure timely report generation. The communication is signed by Dr. Rajeev S., Drugs Controller, Central Licensing Authority, and copied to the CDSCO website and CDTL, Mumbai.
Key Entities Referenced
Directorate General of Health Services: An agency of the Government of India.
Central Drugs Standard Control Organization: National Regulatory Authority responsible for regulating pharmaceuticals and medical devices.
FDA Bhawan, Kotla Road, New Delhi: Location of Central Drugs Standard Control Organization office.
Drug Manufacturers AssociationsExporters: Associations representing drug manufacturers and exporters.
Cough syrup: Pharmaceutical product which is subject of testing.
CDTL, Mumbai: Central Drugs Testing Laboratory in Mumbai, Maharashtra.
State of Maharashtra: A state in India where manufacturer exporters are located.
Dr. Rajeev s Drugs Controller Central Licensing Authority: The signatory of the letter and a Drugs Controller.
F.No. DCGI/MISC/2023/09
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road, New Delhi-110002
Date: 21st June, 2023
To,
All Drug Manufacturers Associations/Exporters
Subject: - Daily Updation of No. of Batches of Cough syrup sample for Export at Different
Laboratories for testing- Request not to submit any sample of cough syrup to CDTL, Mumbai
Lab-reg.
Ref:-File No: DCGI/MISC/2023/09 dated 13" June, 2023 (Copy Enclosed).
Sir, .
Further to this Directorates letter vide File No. DCGI/MISC/2023/09 dated 13th June,
2023, CDSCO publishing daily data w.r.t. to the No. of Batches of Cough Syrup for export in
each lab. Based on the data on 21.06.2023 it is observed that CDTL, Mumbai is having 93
sample of cough syrup under testing and some of the laboratories are not having any sample
for testing.
In view of above, it is requested that
e Manufacturer/ exporter in the State of Maharashtra, Not to submit any sample
at CDTL, Mumbai at present till all the samples at CDTL, Mumbai get
analysed and release the report
e Manufacturer/ exporter in the State of Maharashtra, requested to verify the
Website information of CDSCO on daily basis and submit your samples at the
laboratories which are having no samples/less number of samples.
Your kind co-operation in this matter is solicited for time bound release of reports.
Yours faithfully,
(Dr. Rajeev s
Drugs Controller
Central Licensing Authority
Copy to:
1. Website of CDSCO
2. CDTL, Mumbai