Regarding the action plan for distribution of free medicines, as public health is a state subject, it is primarily for the states/UTs to draw up such action plans as per their need. However, under the National Health Mission (NHM), financial and technical support is being provided to the states/UTs for strengthening their healthcare delivery system including support for provision of free drugs to those who access public health facilities based on the requirement posed by the states/UTs in their Programme Implementation Plans. An incentive of up to 5% additional funding (over and above the normal allocation of the state) under the NHM is provided to those states that introduce free medicines scheme. Under the NHM-Free Drug Service Initiative substantial funding is available to states for provision of free drugs subject to states/UTs meeting certain specified conditions. Detailed operational guidelines for NHM-Free Drugs Service Initiative have also been released to the states on 2nd July, 2015.
The number of free drugs provided by the states varies from state to state and most states have their own list of essential medicines to be provided free in public facilities. As such, support is available to the states/UTs if they decide to provide free essential medicines as per the national list.
The steps taken by the Government to check spurious/sub-standard drugs in the country include:
- Under Drugs and Cosmetics Act, 1940 and Rules made there under, the regulatory control over the drugs imported in to the country is exercised by the Central Government through the Central Drugs Standard Control Organization (CDSCO).
- The manufacture, sale and distribution of drugs are regulated under the said Act & Rules by the State Drugs Control Authorities appointed by the State Governments.
- The regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and inspection.
- The manufacturer is required to comply with the requirements of Good Manufacturing Practices specified under Schedule M of the Drugs and Cosmetics Rules and conditions of the licence so as to ensure that the drugs manufacturers in the country conform to the standards prescribed for them.
Further, the Government has taken following steps to check the menace of spurious/sub-standard drugs:
- The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008. Stringent penalties for manufacture of spurious and adulterated drugs have been provided. Certain offences have also been made cognizable and non-bailable.
- The States / UTs have been requested to set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. 25 States have already set up designated special Courts for trial of cases related to spurious and sub-standard drugs.
- A Whistleblower scheme has been announced by the Government of India to encourage vigilant public participation in the detection of movement of spurious drugs in the country. The scheme provides for suitably rewarding the informers for providing concrete information to the regulatory authorities in respect of movement of spurious drugs. The details of policy are available at the website of CDSCO (www.cdsco.nic.in).
- Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were forwarded to the State Drugs, Controllers for uniform implementation.
- The Government has decided to strengthen both the Central and States’ drug regulatory system during the 12th Five Year Plan enabling them to keep more effective watch on these unscrupulous elements indulging in unlawful activities.
- The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111(as on April, 2008) to 474(as on Feb, 2015).
- Provision of quality assurance for the drugs provided in public health facilities under the NHM.
The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.