Pharma Industry urges Govt to authorize Private labs to test cough syrups

Such a decline in exports would harm India's reputation as the "Pharmacy of the World."

Laboratory lab
Picture: Pixabay

Last Updated on July 22, 2023 by The Health Master

Bottleneck for Cough Syrup Exports

Pharma industry experts are calling on the Union health ministry to take immediate action in resolving the significant backlog of cough syrup samples awaiting testing.

This backlog has arisen due to a recent public notice issued by the Directorate General of Foreign Trade (DGFT), which mandates that all cough syrup samples must be tested before they can be exported.

To alleviate the strain on government testing facilities, industry experts recommend authorizing National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited private testing labs to conduct the necessary tests.


On May 22, 2023, the DGFT announced that the export of cough syrups from India would only be permitted after the samples undergo testing in a government laboratory.

Insufficient Government Testing Facilities:

The experts have highlighted two major concerns with the current situation.

Firstly, there are only 14 Central and state drug testing laboratories responsible for conducting these tests throughout the country.

Given the volume of samples requiring testing, this number is woefully inadequate.

Secondly, these testing labs lack the necessary manpower and infrastructure to process the sheer volume of samples submitted by the pharmaceutical industry.

Recommendations for Improvement:

To address these challenges, industry experts have proposed the following recommendations to the Centre:

  1. Increase the number of testing laboratories to a minimum of 100 immediately.
  2. Ensure a maximum testing time of 72 hours for each sample.
  3. Establish a website that provides real-time updates on the progress of sample testing.
  4. Enable exporters to plan their consignments and dispatch exports based on the submission of samples for testing.

Testing Bottleneck:

The experts express their frustration over the current state of affairs, with numerous samples accumulating at testing laboratories without any testing or report submissions for over a month.

In some states, laboratory staff members refuse to accept samples due to a lack of clarity regarding the payment procedure for sample testing.

These challenges have created multiple issues for companies, significantly impeding their exports of cough syrups.

Discrepancies in Reporting:

The experts highlight a discrepancy between the information provided on the Central Drugs Standard Control Organization (CDSCO) website and the actual situation at the testing laboratories.

While the CDSCO website displays the daily testing load as “under testing,” the reality is that most laboratories reject samples from companies.

Therefore, the actual number of “pending testing” cases is significantly higher than what is indicated on the website.

Impact on Exports:

Export operations rely heavily on strict timelines and delivery dates.

Delays caused by testing bottlenecks can lead to order cancellations, especially in cases where supplies are based on tenders.

Additionally, export stocks are required to have a minimum shelf life to enter certain countries, and prolonged testing delays can result in the cancellation of export orders.

Adverse Reports and Transit Stock:

Industry sources seek clarification on the responsibility for adverse reports.

They suggest that if an adverse report is issued, the onus should be on the exporter to recall the consignment at their own cost.

Furthermore, stocks of cough syrup in transit and dispatched prior to the notification should be allowed to proceed, even if they are currently held up at the borders of Nepal and Bhutan.

Looking Ahead:

Experts caution that unless immediate action is taken to address these issues, the delays in testing could significantly impact pharmaceutical exports, leading to the cancellation of both current and future export orders.

Such a decline in exports would harm India’s reputation as the “Pharmacy of the World.”


The backlog in testing cough syrup samples for export is creating a severe bottleneck in the pharmaceutical industry.

Urgent measures are needed to increase the number of testing laboratories, streamline testing processes, and provide timely updates to exporters.

Resolving these challenges will ensure the smooth flow of exports and safeguard India’s position as a leading global pharmaceutical supplier.

Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.

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