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Health ministry to roll out common IT platform for management of sales and manufacturing licenses of drugs
 
With an aim to harmonize drug licensing system in the country, the Union ministry of health and family welfare is coming out with common IT platform for management of drug sales and manufacturing licenses for all the states and Union territories.

Once the IT platform gets rolled out, information pertaining to drugs being manufactured, their composition, brand names, manufacturers and manufacturing premises will be available in public domain. This will also provide details on drugs which have already received approval from Drugs Controller General of India (DCGI) and are declared rational by Kokate committee or approved by the Supreme Court in various judgments threby helping in identification of irrational products, said NK Ahuja, Haryana drugs controller.

Currently, states have online drug licensing system but there is no uniformity in programming language of IT platform of their FDAs processing application pertaining to sales and manufacturing licences of drugs, said Ahuja.

The common IT platform will provide a complete exhaustive list of approved drugs along with their brand name thus eradicating problem of look-alike and sound-alike drug names. Drugs with similar names result in medication error thus posing a threat to patient safety, he added.

As of now manufacturers get approval for formulations in generic name. Pharma companies are allowed to choose brand/trade name of drugs resulting in unregulated brand names. To rein in it, the health ministry is looking to amend the Drugs and Cosmetics Rules to include a provision for regulating brand names.

It is learnt that once the common IT platform gets ready, manufacturers are required to upload details of their manufacturing sites as well as manufacturing licences on the IT platform which will be ratified by the state FDAs.

The Federation of Pharma Entrepreneurs (FOPE) has welcomed the health ministry's move as it is felt that it will help in generation of comprehensive data base of the pharmaceutical industry in the country which is missing at present. It will help in ascertaining exact number of functional units, eliminate the defunct/non-functional units, details of formulations being manufactured & their composition, brand names of formulations, eliminate same brand name of different formulations - same brand but different composition, identification of irrational products, identification of number of manufacturers of a single formulation to mention a few.

Said FOPE president BR Sikri, We welcome the ministry's initiative requiring all the drug manufacturers in the country to upload details of their manufacturing sites and manufacturing licenses at an IT portal.

In this matter FOPE would like to stress that the government shall ensure complete confidentiality of the data uploaded by manufacturers or license holders. The other point of concern is that the manufacturers currently not manufacturing products as licensed may be required to surrender or get it deleted from the manufacturing license granted by state FDAs. This may cause hardship to the industry and will not be appropriate as the product license is issued only after inspection of the unit on the basis of its capability to manufacture the same.

The matter of developing a common software platform for all the states and Union territories in the country was deliberated in the 54th meeting of the Drugs Consultative Committee (DCC). A detailed presentation on the matter was also made in the 55th DCC meeting.

The health ministry also gave green signal to the initiative. Accordingly the development of the software was initiated. The central government has sanctioned a budget of Rs.2.75 crore in this regard.

The project for the development of the software has been awarded to the Centre for Development of Advanced Computing (CDAC). The software will be developed with the state-of-art technology. CDSCO will undertake the maintenance of the software and will be managed by CDSCO/CDAC. The software is proposed to be developed in phases. The first phase is expected to be launched in 45 days.

The DCGI has urged state and Union territory drugs controllers to make necessary arrangements for providing the requisite IT infrastructure so that the software can be deployed immediately as and when ready.

Further, as the central government envisages having a single software platform for all the states and Union territories in the country, the individual state/Union territory which is in the process of developing new software or enhance the existing software may take a call and coordinate accordingly, said DCGI Dr S Eswara Reddy.
(Pharmabiz.com)
 
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