The tightening of regulations comes two months after DCGI divested state licensing authorities of the powers to issue these NOCs. That decision was taken after the deaths of 84 children in Gambia and Uzbekistan were linked to poor-quality cough syrups from India.
Priyanka Sharma
Published13 Jul 2024, 06:30 AM IST
DCGI has directed pharma exporters to conduct quality checks as specified by the importing country.
Top executives at drugmakers must file legal undertakings detailing their products and manufacturing as well as promise their readiness for government inspections, in case they wish to ship their products overseas.
On 3 July, the Drugs Controller General of India (DCGI) wrote to drugmakers that henceforth, it will issue no-objection certificates (NOC) for exports only once the document is received.
In the legal undertaking, the chief executive or executive director must describe the name of the formulation, quantity being manufactured and exported, place of manufacturing, manufacturing licence and overseas customers, among others.
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Though exporters always had to submit detailed affidavits, this is the first time the regulator has directed top executives to file legal undertakings on stamp paper. The tightening of regulations comes two months after DCGI divested state licensing authorities of the powers to issue these NOCs. That decision was taken after the deaths of 84 children in Gambia and Uzbekistan were linked to poor-quality cough syrups from India.
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Queries sent to a health ministry spokesperson remained unanswered.
Under quality control
The DCGI also directed that exporters must conduct quality checks as specified by the importing country.
“The batch to be exported shall be under quality control testing as per the specifications of the importing country and will comply with all the requirements of the importing country including quality standards,” said a DCGI guidance note seen by Mint.
Besides, medicines meant for exports cannot be diverted for sale in India. In case an export order is cancelled, the drug maker must destroy the entire stock in the presence of state licensing authority. The manufacturer must also maintain records of the transactions of the drugs.
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Besides this, company bosses will also allow the inspection of all the books and records as well as actual usage of drug by the inspector appointed under the Drugs and Cosmetic Act whenever required.