Addressing the issue of Unsafe Drugs and Medical Devices
Deeply concerned about the menace of unsafe and spurious drugs as well as unsafe medical devices, the Commission has set up an Expert Group to go into this issue.
The members of this group being Prof. S.D. Seth, Dr. Prema Ramachandran, Dr. Mira Shiva and Mr. Rajkumar.
Addressing this group, which met for the first time on 16 March 2004, Chairperson Dr. Justice A.S. Anand expressed concern that drugs, which have been withdrawn from the markets world over, are still available in India. He said that unsafe drugs and medical devices take a toll on life and deny a person's 'Right to Life'. Since 'Right to Life and Health' is a matter of concern for the Commission, the problem of unsafe drugs and medical devices needs to be addressed. He also regretted that proper quality control is not being done and even today one-room factories exist in garages like those in and around Delhi.
During the meeting the participants highlighted the fact that at present no guidelines exist to address the problem of faulty medical devices, while clear-cut guidelines have been adopted in other countries such as Australia, USA and Europe. While some States like Tamil Nadu have drawn up a list of essential drugs, others are yet to follow suit, they said. They also pointed out to the large number of combination drugs being manufactured, which makes quality control difficult. They drew attention to the acute shortage of drug inspectors vis-à-vis the ever increasing number of drug manufacturers.
The Expert Committee has been asked to examine the areas relating to:
· Unsafe drugs and medical devices which have not been addressed so far, keeping in mind the Mashelkar Committee recommendation
· The issue of unsafe drugs and medical devices from the perspective of Human Rights
· Evolve appropriate recommendations to various authorities both in the Centre and in the States.
· Study the effectiveness of licensing and monitoring systems
· Suggest steps to strengthen the existing mechanism and machinery for making licensing and monitoring more effective.
The Expert Committee is expected to submit its interim report within three months.
The members of this group being Prof. S.D. Seth, Dr. Prema Ramachandran, Dr. Mira Shiva and Mr. Rajkumar.
Addressing this group, which met for the first time on 16 March 2004, Chairperson Dr. Justice A.S. Anand expressed concern that drugs, which have been withdrawn from the markets world over, are still available in India. He said that unsafe drugs and medical devices take a toll on life and deny a person's 'Right to Life'. Since 'Right to Life and Health' is a matter of concern for the Commission, the problem of unsafe drugs and medical devices needs to be addressed. He also regretted that proper quality control is not being done and even today one-room factories exist in garages like those in and around Delhi.
During the meeting the participants highlighted the fact that at present no guidelines exist to address the problem of faulty medical devices, while clear-cut guidelines have been adopted in other countries such as Australia, USA and Europe. While some States like Tamil Nadu have drawn up a list of essential drugs, others are yet to follow suit, they said. They also pointed out to the large number of combination drugs being manufactured, which makes quality control difficult. They drew attention to the acute shortage of drug inspectors vis-à-vis the ever increasing number of drug manufacturers.
The Expert Committee has been asked to examine the areas relating to:
· Unsafe drugs and medical devices which have not been addressed so far, keeping in mind the Mashelkar Committee recommendation
· The issue of unsafe drugs and medical devices from the perspective of Human Rights
· Evolve appropriate recommendations to various authorities both in the Centre and in the States.
· Study the effectiveness of licensing and monitoring systems
· Suggest steps to strengthen the existing mechanism and machinery for making licensing and monitoring more effective.
The Expert Committee is expected to submit its interim report within three months.