Put pacemakers, stents under price control: FDA

Written By Menaka Rao | Updated:

The FDA had recommended to the Drug Controller of India that life-saving medical devices like stents, pacemakers, orthopedic implants among other things, should be included in the Drug Price Control Order.

The State Food and Drug Administration (FDA) had recommended to the Drug Controller of India that life-saving medical devices like stents, pacemakers, orthopedic implants among other things, should be included in the Drug Price Control Order (DPCO).

The DPCO is an order issued by government of India to control and regulate the price of essential and life-saving drugs. The current list of essential drugs has around 76 drugs and formations.

The Central Drug Standard Control Organisation has written a letter to all the state FDAs on June 22 stating that the Ministry of Health and Family Welfare has constituted a task force for formulating a long term policy for strengthening the drug sector. The meetings will be held by the end of this month or by early August. 

“We have written to the DCI a couple of months back about including these medical devices under the DPCO. These issues will the discussed in the meetings at Delhi,” said PR Uttarwar, the joint commissioner of FDA.

The medical devices include cardiac stents, drug eluting stents, catheter, intra-ocular lenses, orthopedic implants, heart valves, internal prosthetic replacements.

A cardiac stent would cost between Rs1 lakh to Rs1.45 lakh, orthopedic implants cost between 60,000 to 1.25 lakh. In a public hospital, however, a cardiac stent would cost Rs88,500. The FDA had raided some hospitals a couple of months back to check on malpractices in the manner which the stents are stored and sold to patients.

Uttarwar said that they have recommended that cancer drugs should also be included in the DPCO.

“We are also seeking that the generic drugs like paracetamol should not be sold under brand names like Crocin. That increases the price of the drugs to a great extent.”

Doctors have welcomed this move. Dr Suresh Joshi, cardiac surgeon said, “The system is exploiting the poor patients. The whole system needs to be regulated. There has to be transparency in dealing with the patients.”