Haryana to check records of all drug manufacturers related to solvents

Bhartesh Singh Thakur

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Chandigarh, October 14

In view of the Gambia tragedy where 66 children died allegedly due to the intake of contaminated cough syrups produced by Sonepat-based Maiden Pharmaceuticals, the State Drug Controller, Haryana, today issued a circular for checking the records of all drug manufacturers of the past two years related to solvents like propylene glycol, glycerine and sorbitol.

After checking the records at Maiden Pharmaceuticals, violations were found related to the purchase and use of propylene glycol, and notice for the cancellation of their licence was issued.

State Drug Controller Manmohan Taneja directed the drug manufacturers to “sample and test/analyse” each and every container/pack of above said raw materials for impurities like diethylene glycol, ethylene glycol etc. and maintain the graph up to the period specified under Schedule-U appended to Drug Rules, 1945”.

The graph is proof of carrying out tests on propylene glycol. The circular added, “Furthermore, you are directed to submit the certificate of analysis of the abovesaid raw materials along with the graph procured during the last two years in the office of the Senior Drugs Control Officer of your respective zone.”

Schedule U of Drug Rules 1945 deals with particulars to be shown in manufacturing records. For the records of raw materials, it is required that in respect of each raw material, the date of receipt, invoice number, name and address of the manufacturer/supplier, batch number, quantity received, pack size, date of manufacture and date of expiry have to be maintained.

Also, the date of analysis and rejection by quality control, analytical report number with special remarks, if any, quantity issued, date of issue and the particulars of the name and batch numbers of products for the manufacture of which issued and the proper disposal of the stocks have to be maintained too.

As per Section 74 of Drug Rules, the records related to raw material have to be maintained for a period of five years.

Maiden Pharmaceuticals’ cough syrups were found to be contaminated by diethylene glycol and ethylene glycol, as per the WHO.

‘Buy solvents directly from producers’

The State Drug Controller directed all drug manufacturers of Haryana to purchase solvents such as propylene glycol, glycerine and sorbitol complying with the pharmacopoeial standards directly from the producers “having valid drugs manufacturing licence under valid purchase vouchers”.