What are the basic matters that have to be considered while framing the rules to regulate stents?

The device should go through safety animal data, human safety trials, efficacy trials and should be submitted to the regulatory authority seeking approval. The regulatory authority must check the data and decide whether the product should be approved or not. But it will take some time to prepare such norms independently. Since it is urgent to form some regulatory measures, I think, most probably the authorities should adopt the norms from US FDA and CE Mark. I personally feel this would be the best option.

One thing we have to keep in mind is, though the global market for DES is of approximately five million US dollars, only two companies have succeeded to get clearance certificate from US FDA. The same is the case in other countries. This shows that it is not easy to prove the efficacy of these drug eluting stents to attain approval. When we are ready with regulatory measures for such devices, we should make it sure that the indigenous stents should also go through various phases of trials. The phases of trials can be done in a very reasonable cost in India and if the Indian stents are found valuable, it would be a boon for the Indian patients because of the lower cost.

There are allegations that the manufacturers of DES are dumping the device to their distributors without sufficient trials and the dealers are using some shortcuts to distribute it to doctors. What do you think?

As I have said earlier, the question of trials is irrelevant as far as there is no regulatory authority and regulatory measures. I think the allegation about the dealers is also vague, as almost all the medical devices are directly distributed by the dealers to the hospital authorities.

Doctors like me will never buy a product without adequate data. I think most doctors are of the same opinion, since the matter is related with his patient. The central core of the matter is not whether the particular product is good or bad, but it is the reliability of the stent, which is enforced by adequate regulations. All the matters related to distribution and usages are secondary issues.

(Ref : Chronicle Pharmabiz September 15, 2005)

Centre notifies 10 medical devices as 'drugs'

The central government has notified 10 medical devices as drugs that require central clearance prior to import, manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.

The notification became necessary due to an order of Mumbai High court to notify the sterile medical devices for external or internal use in human beings as drugs with immediate effects. The HC order, which came on September 19, was directed against the Drugs Controller General of India (DCGI) and wanted the changes to be notified within three weeks.

With the notification in place, all medical devices manufacturers will have to go by the established procedures of new drug approval through the Central Drugs Standard Control Organisation (CDSCO). The notification has also put an end to the conflicting claims made by the CDSCO and the Maharashtra FDA on the status of medical devices as a drug or not. While the central government was of the opinion that drug eluting stents did not come under the purview of Drugs and Cosmetics Act, the state FDA Had Denied Marketing Permission to a Number of medical devices manufacturing / marketing firms on the grounds that they did not take prior permission from the central authorities.

Interestingly, a prominent section of medical professionals believe that medical devices come under the existing definition of 'drug' in the Drugs and Cosmetics Act. The Act says that 'drugs' includes "all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; such substances (other than food) intend to affect the structure or any function of the human body or intended to be used for the destruction of 18'[vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the central government by notification in the Official Gazette, all substances intended for use as components of a drug including empty gelatine capsules; and such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central government by notification in the Official Gazette, after consultation with the Board".

(Ref: Chronicle Pharmabiz October 13 , 2005, )