The Union health ministry will soon notify heart lung pack, custom tubing pack and perfusion packs used in cardiac surgeries as medical devices under section 3(B) of the Drugs and Cosmetics Act, 1940.
Heart lung packs including custom tubing pack and perfusion packs are used exclusively in combination with heart lung machine and other devices of the system, such as oxygenator, blood cardioplegia delivery systems. The set is used exclusively for transportation of blood and other liquids between the patient and extracorporeal system. This set is not a standard product. It is assembled according to the customer’s specifications. Pack components include, but are not limited to table line, arterial and venous lines, pump lines, arterial filter bypass loops.
The matter was deliberated in detail by the Drugs Technical Advisory Board (DTAB) of the Union health ministry in its 70th meeting held on August 18, 2015. In the meeting, the members were briefed that the heart lung pack was earlier categorised under notified category of ?Disposable Perfusion Sets– vide notification G.S.R. 365(E) dated 17.03.1989 and is being regulated under the provisions of Drugs & Cosmetics Act & Rules thereunder. In view of the absence of specific notification and proper guidelines, the medical devices associations were facing problems in import and manufacture of these medical devices.
The DTAB after deliberations agreed that a clarification may be issued indicating that heart lung packs, custom tubing pack and perfusion packs for cardiac surgeries are medical devices covered under the category of disposable perfusion sets.
DTAB is the highest authority under the Union health ministry on technical matters which was reconstituted by the health ministry under section 5 of the Drugs and Cosmetics Act in February this year. Dr Jagdish Prasad, director general of health services, is the chairman of the newly formed DTAB. Dr G N Singh, Drugs Controller General (India), is the member secretary of the Board.
C Hariharan, director in-charge, Central Drugs Laboratory, Kolkata; Dr. A. K. Tehlan, director, Central Research Institute, Kasauli (HP); Dr G. B. Gupta, vice chancellor, Chhattisgarh Ayush and Health Science University, Raipur; Sudhir Mehta, chairman, Torrent Pharmaceuticals Ltd, Ahmedabad; Dr B Suresh, president, Pharmacy Council of India (PCI); Dr NilimaKshirasagar, chair in clinical pharmacology, ICMR; O. S. Sadhawani, controlling authority & joint commissioner, FDA Mumbai: Dr H G Koshia, commissioner, FDCA, Gujarat; Dr.Madhu Dixit, Central Drugs Research Institute, Lucknow; Dr Rao V S V Vadlamudi, Hyderabad; Dr. P. Dhar, principal scientist, Indian Veterinary Research Institute, Izatnagar; Prof. M. D. Karvekar, Bengaluru; Dr.Muzaffar Ahmad, Rep., Medical Council of India; Dr. A. Marthanda Pillai, Ananthapuri Hospital and Res. Institute, Thiruvananthapuram; and ShejuPurushothaman, government analyst, RDTL, Kerala are the other members of the DTAB.