The drug controller general of India (DCGI) will soon launch a nation-wide drive to check the activities of the medical device manufacturers in the country to ensure the safety and efficacy of the products that are produced by them. Special measures will be taken to scrutinise the business activities of the manufacturers especially the small and medium enterprises (SMEs) to check out for any discrepancies in their manufacturing practices that may impact the quality of the end product.

This initiative shows CDSCO's effort in recognising the medical device industry as an important part of the Indian healthcare system along with the need to have an effective regulatory system specifically targeted to regulate and monitor the medical devices sector.

DCGI Dr G N Singh informed that with a view to safeguard the interest of the public at large all the steps will be taken by his office to ensure that the companies follow all the required norms, rules and regulations as mentioned under the law. He also informed that considering the growing consensus for the need for a separate law for the medical devices, serious consideration is being given to introduce the Drugs, Cosmetics and Medical Devices Bill in Parliament in the coming winter session.

He stressed, “Considering important role that the medical devices play in preserving the health of the patients, it is high time to recognise it as a separate and individual entity in line with the drugs and cosmetics in the country. Since they are different from drugs they should be recognised as a separate entity with different set of rules and regulations that are specific to this sector and we hope that steps will be taken by the government to hasten the process to pass the bill at the earliest.”

As of now, medical device is considered as a drug under the Drugs and Cosmetics (D&C) Act. However, considering the different dynamics of the industry the CDSCO had recently drafted a guidance document called the Drugs Cosmetics And Medical Devise Bill specifically for the medical device industry. Once the bill is passed by Parliament, the D&C Act will be amended to Drugs, Cosmetics and Medical Device Act.

Since handling medical device required different approach, Dr Singh informed that in future if situation demands his office may create additional post for medical device inspectors within the regulatory system consisting of experts and biomedical engineers to monitor this sector