Central Drugs Administration in India

 Rejecting the proposal of the Ministry of Health and Family Welfare to set up a Central Drugs Authority, to check malpractices in drug manufacturing, a Parliamentary panel has, instead, recommended creation of a professionally-managed Central Drugs Administration under the amended Drugs and Cosmetics Act.

In its 79th report on the Drugs and Cosmetics (Amendment) Bill, 2013, the Parliamentary Standing Committee on Health and Family Welfare has said that there was a need for effective discharge of enforcement activities, which requires a strong, professionally-managed administration that can take action against unscrupulous manufacturing companies.

The panel pointed out that neither the Mashelkar Committee report nor the Committee on Health and Family Welfare had recommended constitution of a Central Drugs Authority as proposed in the Bill, but had instead recommended strengthening of the existing Drugs Regulatory body (Central Drugs Standard Control Organisation).

"The proposed Central Drugs Authority is studded with bureaucratic heads of seven central ministries and four secretary and additional secretary/joint secretary-level bureaucrats as ex-officio members with the Health Secretary as its chairperson. Its composition is unprecedented as no other regulatory body in the country or outside has such a composition and it is not acceptable to the Committee," it said.

The Committee said that the central drugs administration should be headed by a chief drug controller general of India of the rank of secretary/special secretary who possesses the requisite technical and professional expertise for the role.

The panel also said that the chief controller general should be selected by a committee headed by the Cabinet Secretary with the review of the functioning of CDA to be done by a panel of independent experts under the Act.

There should be three separate sections dealing with clinical trials, cosmetics and medical technologies, the 

panel noted.

The panel also raised the issue of the flooding of markets with food supplements making claims of possessing medicinal properties and pointed out that the current drug regulating authorities had no control over them.

"The Committee recommends that if any such food supplement claims to have medicinal properties (and) effectiveness in curing disease, they should also be brought under the purview of the proposed Central Drugs Administration for the purpose of their import, sale and distribution," it said.

As regards compensation for injury or death due to clinical trial, the committee has recommended that Principal Investigator appointed by the Chief Drug Controller of India (as recommended by Committee) and the Ethics Committee should be given responsibility for determining the cause of injury or death. The Chief Drug Controller of India should act as Appellate Authority for both, the ``subject’’ and the ``sponsor’’.

The Chief Drug Controller should refer such appeals to the Serious Adverse Event Panel of experts, which will give the final decision, the committee said.

-The Hindu

CDSCO to have staff strength of 5000 in next 5 years, recruitment plan submitted to centre

The Central Drugs Standard Control Organisation (CDSCO) may soon commence a major recruitment drive to strengthen the regulatory machinery at the Centre as the current strength of staff is highly inadequate according to, Dr G N Singh, Drugs Controller General of India.

Responding to a query from Pharmabiz, Dr Singh said CDSCO has made a detailed proposal for recruiting sufficient staff and submitted to the government of India. Response of the government is awaited. Once the proposal is cleared, the appointments will be undertaken on a fast-track basis. With that the staff crunch will be solved and the total strength should be going up to 5000 in next five years. Currently CDSCO has only 340 sanctioned posts including administrative personnel. But not all of them are recruited.

“Compared to US FDA, the manpower strength of CDSCO is far less, but we are still not weak. US FDA has 13000 posts of technical and administrative staff. We are facing the staff crunch for some time and hopefully it will be solved in five years with the recruitment programme envisaged now. Until a few years ago, the situation was worse,” Dr Singh told Pharmabiz.

Crippled with staff shortage, the central regulatory office is struggling to manage the daily operations now. The number of deputy drug controllers and ADCs is less than ten and the posts of drug inspectors have not been filled up fully. With these limited staff CDSCO is handling 20,000 applications, attend over 200 meetings and more than 11000 industry and public representatives. The institution has to respond to around 150 court cases annually, sources from the central agency informed.

According to Dr Singh, the central organisation is also planning to set up a CDSCO Estate in Chennai for its regional office. The present laboratory functioning near Egmore in Chennai will be developed into a modern drug testing lab with all facilities. After demolishing the present building, a new one will be constructed on the site. The estate will contain, apart from the modern lab, a training academy and administrative office.

DCGI said a proposal has been given to the central government to acquire five acres of land in Chennai for the purpose.

HURDLES IN CDA FORMATION

The move to establish a centralized system of drug administration in the country by forming Central Drug Authority is being revived by the Union health ministry now after the proposal got shelved a few years ago. The plan was strongly opposed by the state governments and industry bodies from the very beginning. The health ministry had been wanting to centralize licensing for manufacture, sale, export and distribution of drugs in pursuance of the recommendations of the Mashelkar Committee. And the Drugs & Cosmetics (Amendment) Bill 2007 was drafted to set up the CDA. The Bill was introduced in the Rajya Sabha on August 21, 2007 and was thereafter referred to the Parliamentary Standing Committee of ministry of health. The Standing Committee had then submitted its recommendations to the government dropping the proposal for CDA and instead recommended setting up of a 'central drug administration' as an independent body with headquarters in Delhi and its zonal and sub-zonal offices at state-levels and by strengthening, modernising and restructuring the CDSCO. The health ministry seems to have taken expert opinion on the matter once again and the move now to set up CDA is on the basis of this new thinking.

Formation of CDA was contemplated by the government considering the fast pace of growth of Indian pharmaceutical industry over the years. Need for centralizing the drug control administration was felt on account of the urgency in bringing some uniformity in enforcement of various drug rules. Some of the key provisions of the D&C Act such as Schedule K, Schedule M, Schedule Y, etc. have been already amended and elaborated over the years considering the growth needs of this sector. As per the current system of drug administration, enforcement of all amended rules under the D&C Act is with the state health departments. But, most of the states have not been successful in implementing these amended regulations so far. This, in effect, has been making a mockery of the Act and rules in the pharmaceutical sector. Licensing of products has been one area where there was a lot of confusion prevailed in the country until 2008. A new drug is approved for marketing by CDSCO but issuing licences for its manufacture used to be done by various state drug administrations. Although states and Union territories are having drug control departments, most of them do not have officials with sufficient competence to evaluate an application before a manufacturing license is issued. The issues like these were under discussion by the office of the DCGI for some time but not in a comprehensive manner. All the state governments are still not in support of formation of CDA as that could take away a lot of powers from them. Now, without the support of the state governments and industry, it will be difficult for the health ministry to implement CDA even if the bill gets passed. Therefore, the health ministry needs to take the concurrence of most state governments and the industry again considering the sensitive features of the new system.