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Tracking system a start, but more needed to ensure Indian drug quality

E Kumar Sharma     July 27, 2015

E Kumar Sharma, Associate Editor, Business Today
Indian government's focus on ensuring drug quality is music to ears, especially for those who are still disturbed by the images of November last year when 12 women died at a government-organised sterilisation camp in Chhattisgarh. This, coupled with leading Indian companies like Ranbaxy and now GVK Biosciences getting pulled up by global regulators, has put pressure on the Indian government to have a system of drug authentication that will empower consumers to track and trace the origin of medicines in India.

Technically, we have a tracking system in place if every drug sold is backed by a valid bill and a batch number. But who cares to collect them? Even if we do, the sheer magnitude makes it difficult to track manually. Therefore, a computerised and a web-based track and trace system to track movement of drugs is arguably the best solution to ensure drugs produced and distributed by companies in India are of good quality and not spurious.

If the government were to have its way, all domestic manufacturers will need to incorporate bar coding and Unique Identification Number (UIN) on every pack of medicine, so as to enable effective tracking of the products right from its inception stage to the delivery point. Then, there would be a central portal linked to the entire manufacturer's database. Whenever tracking is done from any point in the distribution chain, the query will be sent to the central portal from where it will be directed to the manufacturer's database.

At the moment, the goal seems to be to have such a system in place that by December this year and if petitions by the industry seeking more time are incorporated, then it may be another year before such a system is in place. But then, as one can guess, it is not going to be easy.
"Whenever there are labelling and tracking efforts like this, I think the real bang for the buck comes when the complementary institutions are also set up which is you have the appropriate IT systems in place, are able to conduct periodic analysis of all the disaggregated data and most important, have in place an effective redressal mechanism when things go wrong," says Chirantan Chatterjee, who teaches corporate strategy and policy at IIM, Bangalore. He, with good reason, feels, it is important that we "hybridise an online tracking system with an offline redressal mechanism with severe punishment dished out to the wrong doers."

In fact, in March this year, when this issue was raised with the Drug Controller General of India G N Singh, he had told the writer then that there were plans to have severe penalty clauses and that "they will be in place once the Drugs and Cosmetics Act, 1940, is amended. Penalties will be so severe that erring drug makers will go out of business," he had said.

But even on the tracking and tracing solution, which, let us assume is the first major step in this direction, there are road blocks. While there seems to a broad consensus within the industry on the need for such a system, the industry is seeking more time as the process involves technological transition involving both time and money.

In fact, the Indian Pharmaceutical Alliance-the platform of many leading Indian pharma companies as its members-has maintained that it is "fully supportive of the system of drug authentication and convinced that it is in the best interests of both, the consumer and the industry there are still issues that need to be addressed satisfactorily before plunging into a major task that will lead to increase in the cost of medicines in the domestic market, require significant investment for augmentation of productive capacities, and has risk of creating shortages of medicines."

The IPA suggests that the Indian Drug Controller or the Central Drugs Standard Control Organisation (CDSCO) "prepare a few model plans to suit units with varying capacities for implementation. The plan should indicate type of modifications required for manual, semi-automatic and automatic packaging operations; the investment required for each model; and the recurring cost of implementing universal global product identification code in the l4 digits Global Trade Item Number (GTIN)."

What seems to work for the industry is that the government seems sympathetic. V K Subburaj, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, says, "most of the units are of small and medium size-around 10,000 of them and there are only 500 units that are big or of reasonable size and many of the small units need financial strength."

Therefore, in a bid to help the small units, he says, there is a proposal to set up a technological up gradation fund to help some the small- and medium-size units. Crucial early steps in the journey to better quality drugs every Indian should have access to.


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