States apathetic attitude impacted implementation of schemes to strengthen State drug regulatory system: Health ministry

New Delhi, April 9, 2022:

Even though the Centre has allocated a higher amount under the centrally sponsored scheme for strengthening the state drug regulatory system, lack of proposals from some of the major states which were provided with higher allocation has impacted the implementation in the year 2021-22, according to the ministry of health and family welfare (MoHFW).

The Centre has allocated funds to the tune of Rs. 175 crore under the Scheme for Strengthening of State Drug Regulatory System, in the Budget Estimate for 2021-22, which was reduced to Rs. 65 crore in revised estimate.

The MoHFW recently informed a Department Related Parliamentary Standing Committee on health and family welfare that it had to propose the decrease to Rs. 65 crore at the RE stage in 2021-22 due to non-receipt of proposals from the state governments.

Some of the major states, with higher allocation of indicative amount, like Maharashtra (indicative amount Rs. 82 crore), Uttar Pradesh (Rs. 68.50 crore), Bihar (Rs. 49.00 crore), Tamil Nadu (Rs. 43 crore), and Karnataka (Rs. 31 crore) did not submit project proposals equal to the indicative amount till it filed the response to the Committee.

The Ministry further submitted that State Governments are being requested time and again for completion of requisite conditions like, setting up SNA, opening of SNA account for the Centrally Sponsored Scheme (CSS) with a commercial bank authorised to conduct government business by state government and its mapping in PFMS, transfer of Central share under CSS to concerned SNA’s account, release of matching State Share by the State Government in single Nodal account and furnishing of Utilisation Certificate of 75% of the central share released during previous years. Subject to fulfilment of these conditions, Central share will be released to the states.

The Ministry further submitted that the Central share under the Scheme was Rs. 850 crore. Rs. 581.30 crore has been released up to March 2021. Another Rs. 65 was to be released during 2021-22. As such, the financial requirement, in addition to BE 2022-23 of Rs. 100 crore will be Rs. 105.00 crore approximately.

In its 134th report presented to both the Houses of Parliament on March 24, the Committee headed by Member of Parliament Prof. Ram Gopal Yadav noted the importance and the huge potential of the drugs manufacturing industry in the country. The Committee also noted the lack of adequate drug control infrastructure and drug testing facilities across the States.

“The Committee strongly believes that for development of a vibrant drugs manufacturing industry, issues related to supply of poor quality drugs need to be resolved. It is an established fact that strengthening of state drug regulatory system is the keystone for addressing the issues of substandard drugs,” it said.

The Committee also noted the plea of the Ministry that the lack of proposals from states for strengthening of state drug regulatory system has been one of the primary reasons for underutilisation under the Scheme.

“The Committee is of the considered view that the non submission of proposals from states especially, states with higher allocation of the indicative amount, is not tenable. The Committee, therefore, recommends that States, especially, Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu, Karnataka may be persuaded to submit the project proposals matching to the indicative amount,” added the report.

The Ministry may also follow up with all the States and make efforts to set up a sufficient number of laboratories, it said. The Committee also emphasised on the need of cooperation between the States and the Union Government to establish a vibrant, dynamic and effective drug regulatory regime. The Committee believes a vibrant network of drugs testing laboratories is crucial for strengthening the drug regulatory environment in the country.

Commenting on the allocation for healthcare in the Union Budget, the committee noted that against a projection of Rs. 93,299.75 crore for the year 2022-23, the Department of Health and Family Welfare has been allocated a budget of Rs. 83,000 crore. The revised estimates for 2021-22 were Rs. 82,920.65 crore and the Budget Estimate 2022-23 allocation of Rs. 83,000 crore, is almost equal to the revised estimates of last year. The budgetary allocation of the ministry of health and family welfare accounts for 2.1% of the total BE 2022-23 whereas the allocation for the ministry of defence is 13.3% of the total budgeted expenditure of the Government in 2022-23.

“The Committee realizes that for a country like India with limited state and Central Government funds, mobilization of resources poses a big challenge. However, this should not deter the governments from increasing its health expenditure and according less priority to the health sector,” it said. It also recommended that the government must increase the investments in the health sector and reiterates its recommendation to increase government health expenditure to 5% by 2025. PharmaBiz