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On finding that a cancer medicine bought for her mother had just few months to go before the expiry date lapsed, Kirti (name changed for reasons of confidentiality), a Mumbai-based consumer, checked with the drug company.
She was assured of the medicine's efficacy, but was left, nevertheless, with an uncomfortable reality. The medicine often reached her with months to go before its expiry-date lapsed — and this, despite the imported drug having a three-year shelf-life.
Probe a little, and similar instances are recounted from different States, regarding imported and locally-made medicines.
In one case, a new generation antibiotic was promoted in the market, just a month away from its expiry date, a State-level drug regulatory official told Business Line .
In another case, a parent found that for 10 years, an asthma drug bought for his child always showed six months to expiry — though the medicine had a shelf-life of 18 months, and it was made locally, recounts the official. The ground reality is that companies are legally in the clear as long as they sell medicines within the expiry date, say drug regulatory officials.
Shelf-life
However, there is an ethical question, if drugs are promoted closer to the expiry date, they admit.
The Drugs and Cosmetics Act mandates that medicines have a minimum 60 per cent shelf-life when imported. But if the medicine is critical and required for the local population, the Drug Controller General of India's office has the discretionary power to allow a medicine with a lesser shelf-life to enter the country.
The problem is that regulators often rely on data from the company to understand the criticality of a medicine, observe regulatory officials. As a result, decisions taken by the Drug Controller's office become a subject of much debate, they add.
In the interest of consumer safety, tighter guidelines are required to reduce the discretionary element involved in approving medicines for domestic sale, suggests a State-level regulatory official.
A mechanism, for instance, that will ensure that domestic companies and multinationals roll-out medicines closer to their manufacturing dates, rather than the expiry date, he adds.
In the process, greater transparency is introduced in the promotion of the drug. Also, it ensures that the country does not become a destination of lesser priority for companies, particularly since India has among the lowest medicine prices, the official points out.
Trade-representatives claim that their channels remain clean, since chemists can return medicines that have expired to the respective companies.
Delay in marketing
Pharma industry representatives, too point out that delay in marketing a medicine is sometimes due to different regulatory processes they need to go through.
Be it a genuine regulatory delay or an unethical strategy to treat the domestic market as low-priority, the Health Ministry needs to revisit its rules, so consumers get medicines with a good part of its shelf-life still intact, says the State drug controller.
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