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Expensive foreign drugs off safety, legal ambit

Rucha Biju Chitrodia

    Can a patient be expected to shell out tens of thousands of rupees to acquire just100mg of a critical imported drug? Apparently, yes. The more unfortunate aspect of this reality is that such a drug might have reached him without a single clinical trial or adequate storage and may thus be rendered useless, says Dr Chandra Gulati, Delhi-based editor of the Monthly Index of Medical Specialities (MIMS).

    According to a recent MIMS editorial, ever since the Drugs Controller General of India (DCGI) allowed the import of foreign finished formulations or ready-to-use drugs by traders, hundreds of exorbitant medicines started entering India. “The exact date or year when import of finished formulations was allowed is not known since there was no formal notification. But by 2003, their number stood at 460, which has now swollen to about 1,000,’’ Gulati adds. Besides, says an official at the National Pharmaceutical Pricing Authority, imported drugs that fall outside price control can be sold at different price levels.

    Dr Suhas Pingle, Maharashtra state secretary at the Indian Medical Association, says these expensive drugs are used in superspeciality medical treatment such as cancer and kidney problems.

    Gulati, though, insists it is incorrect to say that these are used solely by superspecialists. “Some examples of age-old, conventional products being imported would include Vitamin E, Vitamin K, iron, vitamin, mineral and amino acid preparations (for no specific use).’’

    Even assuming that such medicines are being used by superspecialists, says Gulati, is all the more reason for clinical trials to establish proof of a drug’s safety and efficacy. Clinical trials are skipped, says Gulati, because while the registration is mostly done by local branches of foreign drug manufacturers, the actual import and sale is conducted by traders.

    Traders may have little expertise in storage or transport of temperature-sensitive medicines, an important criterion to maintain a drug’s efficacy. Also, since most such medicines are being sold directly by importers (and not through retail chemists), there is no inspection by drug control inspectors to lift samples for random check. A B Ramteke, deputy DCGI, admits that as per norms, a cold chain has to be maintained. But how does a common man know whether this norm has been adhered to? As Dr Surendra Dhelia, member at the Indian Medical Association (IMA), Mumbai, says: “Honestly, I have my own doubts.’’ This once again brings forth the issue of price.

    Dara Patel, secretary-general at the Indian Drug Manufacturers’ Association (IDMA), calls the practice “a lacuna because whatever the landed cost, it is the basis for fixing of price ... Imports by traders who sell at a margin should not be allowed.’’ Patel calls for plugging the loophole by allowing imports only for personal use and in case there are no local alternatives available. Gulati says many such medicines are already being manufactured in India “in abundance’’ such as metronidazole, streptokinase, progesterone, prednisolone, erythropoietin and ketamine. Dr Sachin Almel, consultant medical oncologist at Hinduja Hospital, insists that patients “...rely on the parent company rather than traders’’. A consumer could write in to a parent company and obtain the drug for personal use.

Some imported medicines

Avastin (bevacizumab)
used in colorectal cancer is priced over Rs 28,000 for just one vial of 100mg while the dose is about 300mg every 14 days “till disease progression’’ stops Neorecormon (epoetin beta) used in the treatment of anaemia due to chronic kidney failure. A pack of 30,000 iu is priced at Rs 9,500. One dose is required every week for an indefinite period Pegasys (peginterferon alfa 2a) 180mcg is priced at Rs 17,500. It is used in the treatment of chronic hepatitis B or C. The dose is one injection every week for 48 weeks with a total cost of Rs 8,40,000 Tarceva (erlotinib) 150mg (10 tablets) is priced at Rs 36,000 and is used in certain types of cancers. Dose is one tablet daily “till disease progression” stops






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