The medical device industry wants the government to come out with an interim regulatory mechanism in the form of a guidance document as doubt looms over the introduction of Drugs, Cosmetics and Medical Devise Bill in parliament in the winter session. This demand comes in the wake of delay in finalising appropriate  regulatory guidelines for the medical device sector leading to confusion and holding up of expansion plans of the companies.

The industry fears that under the current political environment it is doubtful whether the bill, which has been stuck in a log jam, will be introduced in the parliament. An industry source said that owing to the uncertainty over the future of the bill, the centre should take some pro active steps to prepare a guidance document for the industry.

Currently, medical device is considered as a drug under the Drugs & Cosmetics  Act. However, considering the different dynamics of the industry the CDSCO had recently drafted the Drugs Cosmetics and Medical Devise Bill specifically for the medical device industry. Once this bill is passed by Parliament, the D&C Act will be named as Drugs, Cosmetics and Medical Devices Act.

However the industry claims that the existing draft bill for the medical devices sector is not as per  the requirement of the industry and needs to be modified  before it is presented in the parliament. Experts claim that it is not feasible to accept the bill in its current form especially since it is prepared in the lines of the regulatory requirements of the pharma industry which is very different from the medical devices sector.

According to an industry expert, D L Pandya who is the programme co-ordinator of the National Biomedical Engineering Society, “Medical devices are very important part of a patients life and are considered as critical life saving products just like drugs as they are implanted directly into the human body for critical care. Implanting low quality or defective device can endanger the life of the patient and that necessitates the need for a separate  minimum standards for these products that are different from the regulatory standards prescribed for the pharma industry. We need a  set of clear cut guidelines to regulate this industry as per the required standards to help propel the growth of this industry in the absence of a separate law.”

Further he pointed out that as many important aspects and requirements specific to medical devices are not mentioned or reflected in the said bill it cannot be accepted by the sector. He added, “This lacklustre attitude to address the industry issues and lack of political will to take a firm decision on the future of the bill is affecting the morale and growth of the industry. We are sure that with adequate recognition the industry will be able to manufacture and ensure the availability of high standard medical devices that are efficacious and safe though out the country.”