Indian industry group calls for clearer expiry date labelling rules for topic drugs

By Gareth Macdonald contact

- Last updated on GMT

IDMA calls for labelling clarification
IDMA calls for labelling clarification

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The DCGI needs to clarify expiry date labelling rules for topical drugs according to an Indian trade group, which says some members’ products are being deemed to be ‘misbranded.’

The Delhi-based Indian Drug Manufacturers Association (IDMA) made the call last month​ after reports drug inspectors had deemed products marked with both manufacturing date and shelf life as misbranded because they lacked a specific expiry date.

The problem – according to the IDMA – is that although labelling is required under Rule 96 in part IX of the 1945 Drugs & Cosmetics rules, drugmakers whose products are in smaller containers are permitted to omit a specific expiry date under Rule 96(B) (IV).

In a letter to the Drug Controller General (DCGI) IDMA president S V Veerramani wrote that “The prevailing industrial practice world-wide as well as in India is batch number and either date of manufacturer or date expiry is printed or embossed on the crimp of the tube.

Most of the time ‘date of manufacture’ is printed on the crimp with a statement on the tube explaining  that date of expiry will be X years from the date of manufacture​” he said, adding that “this practice is followed as the space available on the crimp is limited​.”

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