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Yet another go at FDCs?


new-viveka-100x100We seem to be slowly but surely moving towards the Centre’s goal of substituting branded medicines with generics. A Ministry of Health & Family Welfare notification dated March 13th mandates that the ‘proper name’ (read generic name) of the drug or fixed dose combination (FDC) drug needs to be printed at least two font sizes larger than the brand/ trade name, or the brand/ trade name should be written in brackets below or after the generic name. The notification also specifies that the brands can be substituted.

The ruling is not applicable to FDCs of vitamins and FDCs containing three or more drugs. While it is true that there is no space on a medicine pack to print more than two or three generic names, isn’t this a loophole begging to be used? No doubt there are some FDCs which have proved their usefulness. Dr Nilima Kshirsagar, National Chair Clinical Pharmacology, ICMR, for instance points out that many anti-TB medicines contain more than three medicines. But could the exclusion indicate the regulator’s intention, over time, to weed out FDCs with more than three constituents? Replying in her personal capacity, Dr Kshirsagar is of the opinion that it would be very useful and important to also have information for patients to be put with the package. At present, the package insert contains information for prescribers. She is the chairperson of a sub committee appointed by the Drugs Technical Advisory Board (DTAB) to have a relook into these cases.

As part of this review, a notice dated March 12 requested the All India Drugs Action Network (AIDAN) to revert with its recommendations by April 7, but this looks unlikely now, with the AIDAN asking for a month’s time to review the FDCs. This is understandable as the task involves gathering quite a lot of scientific data. The DTAB sub committee has specified that all information on composition/ product details and its opinion on the therapeutic justification, safety, and efficacy for each ingredient of these FDCs should be part of the submission. All opinions have to be accompanied by a one page summary with supporting scientific evidence of a maximum of five relevant published articles. The submission needs to conclude with a recommendation if restriction or regulation instead of prohibition will be sufficient to control the manufacture and use of the FDCs under examination.

Secondly, the AIDAN wants a reconstitution of the sub committee, saying that representatives of industry associations like the Indian Pharmaceutical Association and Indian Medical Association have a conflict of interest as many are affiliated to the pharma industry. Thus, while the wheels have been set into motion yet again, FDCs are too much part of the pharma market in India to disappear with a single order.

On a slightly more positive note, Dr Eswara Reddy’s first month as DCG(I) has seen not just the transfer of around 40 drug regulatory staff, but also a few key structural tweaks and outreach activities. The initiative to set up a public relation office (PRO) at the CDSCO headquarters at FDA Bhavan, New Delhi, headed by an assistant drug controller and supported by two drug inspectors, is a good move. As is the formation of the Indian Drug/ Pharmaceuticals Association Forum, consisting of six industry bodies. Two high ranking representatives of each association will be invited each quarter for a discussion with the DCG(I) on issues related to CDSCO.

While the list comprises Indian Pharmaceutical Alliance, Indian Drug Manufacturers Association, Bulk Drug Manufacturers Association, Federation of Pharma Enterpreneurs, Confederation of Indian Pharmaceutical Industry and Laghu Bhartiya Udyog (representing MSME pharma companies), the Organisation of Pharmaceutical Producers of India (OPPI), comprising the India-based subsidiaries of MNCs, is not part of this list. Maybe CDSCO felt that members of these six associations faced different issues and therefore intends to have separate meetings with OPPI. Kanchana TK, Director General, OPPI confirmed that they ‘have registered our disappointment with the relevant Ministries for not being included in the list of Associations identified for the constitution of Indian Drug/ Pharmaceuticals Association Forum and have requested for a modified Office Order.’

But perhaps the most welcome step, with immediate benefits for pharma exporters, is the waiver of the no-objection certificate (NOC) in the shipping bills required at CDSCO’s port offices. The waiver is only for shipping bills filed by manufacturers with valid licenses and requires a copy of the license to be included in the export documents. While the NOC for pharma exports to major markets like the US, Canada, Japan, Australia and the EU was waived a couple of years back, the March 21 notification extends it to all other countries. This should go a long way towards easing India’s pharma exports. The safeguard to restrict the waiver to manufacturers is understandable given the concerns about quality.

All these measures take forward the steps put in motion by the previous DCG(I), Dr GN Singh, to streamline processes in line with Prime Minister Modi’s mantra to increase the ease of doing business. There are good signs that this tempo will be maintained and we wish Dr Reddy all the best.

Viveka Roychowdhury

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