Bhartesh Singh Thakur
Chandigarh, October 15
Sonepat-based Maiden Pharmaceuticals Limited, under the scanner for the death of around 70 Gambian infants due to the "consumption" of the company's four cough syrups, appears to have "forged" test reports of raw materials such as propylene glycol, documents accessed by The Tribune point out.
According to the show-cause notice issued by the Haryana drug regulator to the company for the cancellation of its licence, propylene glycol with batch number E1105149 was received and analysed on March 23, 2022 (vide report MPLR032304), but the same analytical report was used in the manufacture of 'MaGrip N Cold Syrup' (batch number ML21-198) in December 2021. Surprisingly, the raw material tested in March 2022 was used to make a cough syrup three months earlier in December 2021. MaGrip N cold syrup is one of the four syrups banned in Gambia following the death of infants.
Another glaring violation mentioned in the notice is the difference in the expiry dates of propylene glycol (PG) and the products manufactured out of it. While PG with batch number E009844 (manufacturing date September 2021) was shown to have an expiry date of September 2023, three cough syrups — Promethazine oral solution BP, Kofexmalin baby cough syrup and Magrip N cold syrup — made with the same PG showed an expiry date a year later in November 2024. "How can the raw material and the product manufactured with the same raw material have different expiry dates," questioned a drug analyst.
Also, the batch numbers of PG, sorbitol solution and sodium methy paraben were found missing from the certificate of analysis reports. "A drug manufacturer has to test each and every raw material before use. Small-scale units like Maiden Pharmaceuticals don't have expertise or equipment for gas chromatography to test propylene glycol. They rely on forged reports," said former State Drug Controller of Haryana GL Singhal.
Another expert said on anonymity that Maiden Pharmaceutical's data looked "fabricated". It has also come to light that data related to batch number, manufacturer name, manufacturing date and expiry date was not found maintained on the purchase invoices of excipients, including propylene glycol, at the firm's premises.
"The company has not performed quality testing of propylene glycol for diethylene glycol and ethylene glycol," mentioned the show-cause notice. A large number of drug manufacturers procure raw materials from a supplier, but the latter is supposed to have a valid drug manufacturing licence.
Glaring anomalies
- Raw material's test report was of March 2022, but it was used to make cough syrup 3 months earlier in Dec 2021
- Raw material had expiry date of September 2023, but the product made with it had expiry date of Nov 2024
from The Tribune https://ift.tt/hwMAiUT
No comments:
Post a Comment