To ensure maximum assistance to the SME sector, the Small and Medium Pharmaceutical Industry Centre (SMPIC) will help the SMEs to solve their technical problems and issues with the help of the experts at the NIPER. The SMPIC will gather the complaints and queries from the SMEs and forward the same to the concerned sections at the NIPER for an early solution and guidance; it was decided at a recent meeting of the consultative committee.

Besides, the SMPIC will soon launch the series of workshops aimed at training the SME people on crucial and much-needed technical and regulatory aspects. A sub-committee had already made recommendations to the SMPIC consultative committee on the training modules and programmes to be conducted by the centre.

The SMPIC will also facilitate impurity preparation/ and characterization work of pharma SMEs in the project mode by NIPER. A list of APIs in this purpose was prepared by the chairman of the consultative panel and has already handed over to the NIPER. The centre will also be coordinating with Pharmexcil officials for making a work plan on the input-out norms for APIs as stipulated by the Ministry of Commerce.

The National Pharmaceutical Pricing Authority (NPPA) will soon finalise the first Pharmaceuticals Census of India (FPCI). To develop a comprehensive and dependable database to help policy-makers and other stakeholders, the national drug price regulator had launched a campaign way back in February 2008.

Under this campaign, the NPPA has already collected data from 6299 pharma units scattered all over the country through structured questionnaires under the FPCI. It will soon prepare the final report after getting the data compiled and processed by an agency for which the NPPA has already issued an expression of interest.

The final report will provide a pharmaceutical map of India that will exhibit and illuminate all those districts of the country where pharmaceutical manufacturing units exist. It will detail about the investment in plant & machinery, land & building by pharma manufacturing units in the country by class of industry at disaggregated levels of administrative set-up (state-wise/district-wise) and the turnover of the units by class of industry, state-wise and district-wise and also by type of units i.e. formulation or bulk drugs.

The final report on the FPCI will explain about state-wise and district-wise employment generated in the country by the pharma sector, by class of industry, gender-wise, and by type of units. It will give details about the state-wise and district-wise pattern of consumption of inputs by source by manufacturing units; pattern of consumption of 'utilities' by manufacturing units; pattern of expenditure on R&D, clinical trials and quality control; and pattern of inventory of semi-finished goods, finished products. There will be details about the working capital, loans outstanding and interest accrued; and distribution of manufacturing units by number of products.

The report also have details about the distribution of number of manufacturing units who hold WHO-GMP certification and the number and pattern of export-oriented pharma manufacturing units and countries of destinations.

In order to regulate the growing biosimilars market in the country, the Department of Biotechnology (DBT) is planning to frame some regulations on the lines of the Hutch-Waxman Act of the USA which regulates generic pharma market in the US. At present, there is no separate regulation to govern the biosimilars market in India.

It is expected that if things go as per plan, there will be an independent regulatory body for biosimilars by August this year. In this regard, the DBT will soon to discuss the possibility of having India's own regulation for biosimilars. The meeting will focus on the urgent need for written guidelines for biosimilars.

Pesently, the biosimilars in India are governed under the Environment Protection Act of 1970, Order 1989 and the Drugs and cosmetic Act. Even though the subject of biosimilars is dealt under these provisions it does not provide much needed regulation with respect to biosimilars. It is to address a furious problem that DBT has initiated steps for having a separate set of regulations for the biosimilars.

Biosimilars appear when a bio-drug patent, which gives the original developer exclusive marketing rights, expires. Unlike generics, biosimilars are not produced chemically but biologically, taking a biotech drug as a reference.

A 33-member mega committee was set up for this purpose in 2008 to look over the matter with Dr V P Kamboj acting as the chairperson of the mega committee.

The expert committee on the pentavalent vaccine has recommended to the government to introduce the controversial vaccine in the country in phases. The panel has been constituted by the Union Health Ministry to look into the issue of introduction of five-in-one or pentavalent vaccine under the national immunisation programme.

The expert committee, headed by Indian Council of Medical Research (ICMR), Director General Dr V M Katoch, has recommended to the government that the vaccine merits introduction in the country's immunisation programme in phases after studying the impact assessment in each phase. The expert panel, which was asked by the ministry to examine the entire gamut of health issues related to the proposed introduction of the vaccine in the national immunisation programme, has submitted its report to the Union Health Ministry.

The expert committee, analysed all the five vaccines separately and the prevalence of the diseases covered by the vaccine in the country. The committee had constituted separate sub-committees on each of the five vaccines included in the pentavalent vaccine. The sub-committees also examined the mortality rates caused by each vaccine in the country. The diseases covered by the five-in-one vaccine are diphtheria, tetanus, pertussis (whooping cough), hepatitis B and haemophilus influenzae Type B (often known as Hib) which causes some severe forms of pneumonia and meningitis.

Sanofi-aventis, Shantha Biotech, Serum Institute of India, Bharat Biotech and Panacea Biotec are among the major companies that had introduced pentavalent vaccines in the domestic market.

The government has urged the World Health Organisation (WHO) to address the issue of spurious, substandard drugs through an effective alternative instead of confusing it with the 'counterfeit medical products'.

The government has proposed to the WHO that the term 'counterfeit' should not be used as an equivalent of fake or spurious drugs.

The term 'counterfeit' instead relates to IP infringement. The existing forum within WHO to deal with issues related to anti-counterfeit medical product is called International Medical Products Anti Counterfeiting Taskforce (IMPACT). Neither the anti-counterfeiting taskforce, nor its terms of reference have been approved by any governing body of WHO, the government argues in the proposal it is tabling at Geneva where the World Health Assembly is being held.

Additionally the proposal has also raised the question of the conflict of interest in the task force's composition. The civil society has been raising this issue in last few years, raising their decibel in the run up to the meet.