While the market is increasingly flooded with self-diagnostic medical equipments such as blood pressure monitors, alongside digital variants of the humble thermometer, can a common man be assured that their readings are foolproof? A Bangalore resident has been facing problems with his portable BP meter since September. In Mumbai, a diabetic was shocked to find that the results of his imported glucometer (a device to monitor blood glucose levels) vastly differed from those of a pathology laboratory. Such cases are not uncommon.
Dr Chandra Gulati, editor at the Monthly Index of Medical Specialities (MIMS), says they occur because not all diagnostic equipment are currently regulated. "There is a regulatory problem as a large number of devices are not notified as drugs by the Drugs Controller General of India (DCGI)."
This, says Gulati, is a violation of the Drugs and Cosmetics Act. According to the Act, the term "drugs" includes "all medicines for internal and external use of human beings and animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder..."
Consumers, however, can hope for the inclusion of these equipments in the near future. A senior official in the ministry of health says a sub-committee has been set up by the Drugs Consultative Committee, a statutory body under the Drugs and Cosmetics Act, to work out proposed additions to the list of medical equipment notified as drugs.
So far, only 10 items, including cardiac stents, catheters, bone cements, intra ocular lenses, orthopedic implants and heart valves have been notified.
Thus, for now, says S P Adeshara, commissioner at the Gujarat’s food & drugs control administration, "Of the several thousand devices, only those notified by the government of India are to be regulated."
These 10 items were included in 2005, "in the wake of a Bombay high court order on cardiac stents", says Gulati. This order, adds Gulati, followed clinical trials where drug eluting stents were used on 89 patients without regulatory approval from the DCGI or permission from the hospital’s ethics committee. While hearing the PIL, Gulati says, the DGCI submitted to the court that stents were not drugs and hence not subject to prior approval. The high court pointed out that as per the definition of drugs as stated in the Drugs and Cosmetics Act, stents should be treated as drugs, Gulati adds.
The ministry of health official says the DCGI is taking one step at a time in the inclusion of medical equipment. "There are plans to bring in more items, but we have started from critical items and are moving towards non-critical." Consumer organisations and medical practitioners TOI spoke to, however, say diagnostic equipment used to monitor serious health conditions on which an entire line of medication is based cannot be deemed non-critical. Till the guidelines come into force, all a consumer can hope is that the kits function as promised. On their part, companies say they provide in-built systems to verify whether a kit is functioning optimally. Doctors add that readings can go haywire if the kits are not stored in dry, cool environment or used as per specified instructions.
Dr Chandra Gulati, editor at the Monthly Index of Medical Specialities (MIMS), says they occur because not all diagnostic equipment are currently regulated. "There is a regulatory problem as a large number of devices are not notified as drugs by the Drugs Controller General of India (DCGI)."
This, says Gulati, is a violation of the Drugs and Cosmetics Act. According to the Act, the term "drugs" includes "all medicines for internal and external use of human beings and animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder..."
Consumers, however, can hope for the inclusion of these equipments in the near future. A senior official in the ministry of health says a sub-committee has been set up by the Drugs Consultative Committee, a statutory body under the Drugs and Cosmetics Act, to work out proposed additions to the list of medical equipment notified as drugs.
So far, only 10 items, including cardiac stents, catheters, bone cements, intra ocular lenses, orthopedic implants and heart valves have been notified.
Thus, for now, says S P Adeshara, commissioner at the Gujarat’s food & drugs control administration, "Of the several thousand devices, only those notified by the government of India are to be regulated."
These 10 items were included in 2005, "in the wake of a Bombay high court order on cardiac stents", says Gulati. This order, adds Gulati, followed clinical trials where drug eluting stents were used on 89 patients without regulatory approval from the DCGI or permission from the hospital’s ethics committee. While hearing the PIL, Gulati says, the DGCI submitted to the court that stents were not drugs and hence not subject to prior approval. The high court pointed out that as per the definition of drugs as stated in the Drugs and Cosmetics Act, stents should be treated as drugs, Gulati adds.
The ministry of health official says the DCGI is taking one step at a time in the inclusion of medical equipment. "There are plans to bring in more items, but we have started from critical items and are moving towards non-critical." Consumer organisations and medical practitioners TOI spoke to, however, say diagnostic equipment used to monitor serious health conditions on which an entire line of medication is based cannot be deemed non-critical. Till the guidelines come into force, all a consumer can hope is that the kits function as promised. On their part, companies say they provide in-built systems to verify whether a kit is functioning optimally. Doctors add that readings can go haywire if the kits are not stored in dry, cool environment or used as per specified instructions.