Drug regulator set for a revamp

Aesha Datta New Delhi | Updated on December 28, 2014 Published on December 28, 2014

But funds allocated not adequate, say officials

The Centre has approved a scheme for upgrading the drug regulator – both at the Central and State levels.

However, the allocated funds may not be adequate for overhauling the regulatory bodies that have been facing a resource as well as manpower crunch, resulting in poor quality control.

According to a notice by the Ministry of Health and Family Welfare, a ₹1,750-crore scheme has been launched for strengthening the Central Drugs Standard Control Organisation (CDSCO) and the State drug regulatory systems.

Of this, the amount sanctioned for the CDSCO is ₹900 crore and ₹850 crore for States.

However, a senior official in the Ministry said that the initial proposal was for a minimum of ₹3,000 crore — ₹1,800 crore for CDSCO and ₹1,200 crore for the State systems.

“The allocation of ₹900 crore is the bare minimum that is required for adequate functioning of CDSCO. We had made a proposal to double that sum, which would allow us to train drug inspectors, upgrade and add more laboratories etc,” the official said.

While resources are inadequate to train even the existing staff, another official working with CDSCO admitted that they are also facing huge manpower shortages.

Manpower crunch

“We need to at least double the number of existing inspectors across the country to conduct even basic scrutiny of drug manufacturers. We are working with just skeletal staff,” the official said.

Between August and November, the drug regulator has repeatedly marked several drugs of different brands as not of standard quality, spurious or misbranded.

In August, 22 such drugs had been identified by the CDSCO, which rose to 45 in September, 16 in October and 24 in November.

These included many common medicines such as antibiotic amoxycillin, gastric medicine ranitidine, pain-management medicines such as diclofenac and others.

According to a study by industry chamber Assocham, the fake drugs market in India is likely to cross $10 billion mark by 2017 from the current level of about $4.25 billion.

Last December, Drugs Controller General of India GN Singh had forwarded a proposal to the Government for increasing the number of inspectors from just 1,500 to 5,000 by 2017. However, with inadequate funds, this may take a hit.

With the Central regulator processing over 20,000 applications a year, lack of funds, time and manpower have resulted in gaps in quality checks, highlighted by several crackdowns on local manufacturers by the US Food and Drug Administration.

The proposed scheme, under the National Health Mission, would be on a 75:25 sharing pattern with States and Union Territories, resulting in total funds of about ₹1,079 crore for the strengthening of State regulators, with the States’ share being ₹229 crore.

According to the Government notice, the aim would be to strengthen drug safety infrastructure at State level; set up new laboratories and upgrade the existing ones; and to create regulatory posts and provide basic and advanced training of officials.

Further, the allocated ₹900 crore for CDSCO would be used to set up a training academy besides improving existing infrastructure, setting up new laboratories as well as instituting an e-governance mechanism.

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Published on December 28, 2014
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