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CONSUMER
WATCH
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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