Wide-ranging issues from upgrading of regulatory system to match with the global mechanism, interstate cooperation to curb on substandard drugs movement, and to bringing in checks on medical devices formed part of the discussions at the two-day meeting of the 37th Drugs Consultative Committee, began here on Monday.
The matter of creating good system of intelligence-cum-legal wings, efforts to generate information and prepare dossiers on the culprits, sharing of information with stake-holders to facilitate curbing this menace, harmonization of procedure through joint efforts by the States and regulators and amendment of the DMR (OA) Act also came up for deliberations.
Inaugurating the meeting, Union Health and Family Welfare Minister Dr Anbumani Ramadoss called for inter-State cooperation to prevent and curb the movement of substandard and counterfeit drugs.
``The Government is aware of the significant role the drugs and pharmaceuticals play in the health care system. It is taking lot of initiatives to upgrade the country's regulatory system with that of global regulatory system,'' he said.
As a part of this exercise, the Government of India was trying to have proper coordination with US FDA. One of the major concerns of the Government was the lack of system and uniformity within the States. Time has come for the regulators of State Governments to join together and harmonize a procedure within the country, which is essential before an effort is made for global harmonization, he said.
As a part of global harmonization exercise, the Government was taking initiatives to have working relations at regional level with International Conference on Harmonization (ICH) on drug legislation for human use. The Government was looking for opportunities for bilateral agreements for mutual recognition, the Minister said.
``One of the major concerns relate to advertisements with tall claims by some of the unscrupulous manufacturers and the products without adequate evidence of its use. Though [DMR(OA)] Act is responsible for controlling such advertisements, it does not help as it is a very old Act and some of the current activities carried out are advertisements through electronic media with tall claims and advertisements by unscrupulous persons about the cure for critical illness like Diabetes, Asthma etc., to cover up all these things. The DMR (OA) Act is, therefore, being amended,'' he said.
The meeting also took up the follow-up actions on its earlier guidance documents for Good Storage Practices and Good Laboratory Practices. All the Drugs Controllers should ensure that these practices are followed precisely and meticulously, as they will protect quality of drugs distributed, it was felt.
Recently the Government has declared some of the critical medical devices as drugs and was trying to control their quality through registration of their import and licensing for local manufacturers. The States were asked to take initiatives for ensuring the quality of these medical devices as they also play an important and critical role in the safety of patients.
It was also felt that the DCC should meet more often to sort out problems relating to implementation of Rules and Regulations for Drug Control and Distribution.