Odisha panel bans drug with shelf life of more than 5 years

BHUBANESWAR: The state Directorate of Drugs Control Administration (DDCA) has banned the sale of an imported steroid after it found that its shelf life was more than five years. According to Drugs and Cosmetics Act, 1940, the expiry date of a medicine should be within five years of its manufacturing date.
DDCA sources said it seized Medrol (Methylprednisolone) tablets of 4 mg and 16 mg imported by Pfizer Products India, Mumbai, from the US.Medicines worth Rs 5 lakh were sealed in the last one week.
Confirming the development, drugs controller Hrusikesh Mohapatra on Friday said since licensing authority of the imported drug is the Drugs Control General of India, the DDCA has informed the central regulator of the matter and sought its advice for further action.
Official sources said Medrol has a maximum retail price of Rs 41 for 10 tablets of 4mg and Rs 182 for 14 tablets of 16 mg. It is used to treat inflammatory conditions such as allergic disorders, arthritis, psoriasis, endocrine disorders among others.
Acting on a tip-off, the DDCA raided the premises of the carrying and forwarding agent and subsequently asked the company to recall the product. It also sent samples for quality testing, the sources said.
Responding to TOI queries, a Pfizer statement said, "The matter pertains to the labelling on certain batches of its product. It is being interpreted (by DDCA) as a 61 month expiry in 2019 due to the format of the labelling. There is no quality issue with this drug. We are in dialogue with the drug authorities to resolve this matter."