The Indian Drug Manufacturers Association (IDMA) has urged the office of DCGI to issue necessary guidelines with regard to printing of manufacturing and expiry dates on tubes containing ointments and creams. Currently pharma companies marketing ointments in tubes are printing only manufacturing dates with a text stating expiry after a period of 24 months or 36 months.

The issue has come up after a few members informed IDMA about the drug inspectors raising objection for not printing expiry dates on tubes in plants of these members. Inspectors declared the products without expiry dates are misbranded and have also instructed the manufacturers to print or emboss both the date of manufacture and expiry.

As per the Rule 96, in part IX of Drugs & Cosmetics Rules 1945, the manner of labeling particulars shall be either printed or written in indelible ink on the label of the innermost container of any drug and every other covering. It will include- The name of the drug, net contents, the strength of active ingredients, the name of the manufacturer and the address of the premises of the manufacturer, a distinctive batch number, manufacturing license number and date of manufacture and date of expiry

But the Rule 96(B) (IV) provides for certain exemptions if the drug is in an ampoule or a similar small container, the date of manufacture is printed on crimp with a statement on the tube explaining that date of expiry will be X years from the date of manufacture.

S V Veerramani, president of IDMA says, “the matter was brought to our notice by some members and we have requested the DCGI to look into the matter and issue necessary guidelines so as not to declare such drugs as misbranded and amend the drug rule as necessary so as to regularise the practice.”

He informed in India, many drugs are marketed in various topical dosage forms like ointments, gels and creams which are packed in tubes. These tubes can be of various sizes. The prevailing industrial practice world-wide as well as in India is to print batch number and either date of manufacture or date of expiry on the crimp of the tube. Most of the time, date of manufacture is printed on crimp with a text on the tube explaining that date of expiry will be X number of months from the date of manufacture. This practice is followed as the space available on the crimp of the tube is limited.

In the letter written to DCGI, IDMA also informed that this practice is being followed almost from the commencement of pharmaceutical manufacturing and packaging of the tubes in India. All the required information is being provided in the manner of labeling and it is being observed without any inconvenience to the patients for last many decades.