The Union health ministry will not take a 'hasty decision' on the introduction of 2D bar code for every strip of medicine produced in the country by amending the Rule 96 of the Drugs & Cosmetics Act, as a case is pending in the Allahabad High Court and the industry is opposing the move.
Sources in the Ministry confirmed that it would not go for a 'hasty decision' and the ministry did not want to be dragged into the controversy. “The Drug Technical Advisory Board is yet to make a recommendation in this regard. We will wait till the High Court takes a call on the matter as the case is sub-judice,” a senior official said. The introduction of the bar code can be made by amending Rule 96 (manner of labelling requirement) only, he added.
The Union Minister of State for Health Dinesh Trivedi also made a similar statement in the Parliament recently. “The Allahabad High Court in the criminal writ petition (no 16212/2008 – Brahmaji vs State of UP and others) is seized of the issue of developing a drug tracking system. In that connection, the Drugs Consultative Committee, a statutory committee of States’ drug regulators has recommended the proposal to have barcode and unique numeric code for every strip of medicine, for consideration of the Drugs Technical Advisory Board, another statutory technical committee. The matter is sub-judice.” he said.
The stand of the Ministry comes in virtual contradiction of the reported move by the Drugs Controller General of India (DCGI) who advised the industry to go for bar codes, despite the case being under the consideration of the court. According to earlier reports, the DCGI wanted to introduce unique indentifier code and 2D bar code by which one can verify the drug through SMS.
It may be also recalled that the HC allowed the Indian Drug Manufacturers Association (IDMA), representing small, medium and large Indian drug manufacturers, when the case came up for hearing in the Court on March 13. The court has asked the IDMA to file an affidavit by April 15 on the matter.
Commerce Ministry, meanwhile, has notified the introduction of bar code for exports of all pharmaceutical products from July 1.