Drugs in India lose 3-4% of their potency at chemists’ shops because they are not stored properly, results of a recent study show.
The year-long study by the Delhi Pharmaceutical Trust, or DPT, a body of pharmaceutical scientists and senior pharmacists, shows that “degradation” occurs in medicines much before they approach the expiry dates put on the packs due to uncontrolled temperature, exposure to light and moisture, and, among other things, when they are transported from the manufacturing site to retail points and retail shops.
Affecting quality: A pharmacy in south Delhi. (photograph by Rajeev Dabral / MINT)
The survey, a first of its kind in India, covered drug stores in and around New Delhi in 2006 and 2007. The findings were released last month. The study did not have any sponsor.
The focus was on selected brands of four drugs—cephalexin, ranitidine, rifampicin and the ampicillin-cloxacillin combination—manufactured by reputed drug makers.
It, however, did not reveal the names of the companies that make these drugs, widely prescribed for anti-bacterial infection, acidity, tuberculosis and other infections. In fact, almost all major drug companies in India make these drugs under various brand names.
“Our study, as a pilot project, aimed at sensitizing the drug makers as well as the distribution channels that there is an urgent need for awareness about the maintenance of good storage system at every level of drug distribution,” said Praveen Kullar, a DPT trustee and president of the Indian Pharmaceutical Association’s New Delhi branch.
The trust has made recommendations to the Indian PharmaCopoeia Commission, which brings out the drug standards that indicate the quality and efficacy of drugs in India, alerting it on the need of changing the general chapters of the pharmacopoeia with regard to drug storage.
The survey was undertaken to scientifically capture the variations observed in the temperature and humidity levels at various chemist outlets in New Delhi and study the real-time effect of the storage and stability of various pharmaceutical products.
The drugs have shown various levels of degradation in potency, far higher than the permissible limit, at the outlets that did not maintain specified temperature, light or humidity levels, the report said.
“Since the study included only a limited number of products and locations, we are yet to get the complete picture of variations in degradation. But we made sure that all the parameters and methods used to analyse the drug degradation in these stores are comparable with other regions of the country,” said another DPT trustee, who didn’t wish to be named.
According to him, since these products are made by only big and reputed firms, which normally ensure proper drug stability while manufacturing and packing, degradation in drugs manufactured by small companies could be much larger.
Currently, there are no codified norms in India on storage practices, though guidelines in the pharmacopoeia such as “good storage practices” and “good pharmacy practices” talk about temperature, moisture and light-controlled storage requirements in warehouses and chemist outlets.
A scientific committee on drug quality, headed by former director general of the Council of Scientific and Industrial Research R.A. Mashelkar in 2003 had recommended incorporation of these guidelines in the Drugs and Cosmetics Act. This would have forced wholesale and retail outlets to follow the storage norms, but the government, in the face of stiff resistance from the traders who fear higher cost, has not implemented it.
A 2007 order from the central drug regulator to state food and drug authorities, asking them to enforce air conditioning in all drug outlets also faced strong protest from the wholesale and retail traders.
Drug controller general Surinder Singh was not available for comments over the weekend.
Though most of the retail outlets in cities and towns use one or two refrigerators to keep drugs such as vaccine and injections that bear a tag of “below 20-degree temperature”, it is not often followed by many. Also, such arrangements may not be adequate to store all such packs. Chemist outlets tend to avoid storage specifications because of high electricity costs.
“A concessional electricity tariff, as it is allowed to hospitals and nursing homes, might help them improve the storage system,” says Kullar of DPT.
“Also, measures such as offering cooling devices and marking of light and temperature-sensitive products with colour code by the drug makers would help them combat these issues.”