With the industry still opposed to the idea of implementing barcode in the proposed format for pharmaceutical exports from July 1, the Commerce Ministry is likely to relax the norms and implement it in a phased manner, depending on the suggestions from the industry gathered by March 31.

Though the Commerce Ministry wants to go ahead with the proposed 2D barcoding and unique 'randomly generic numeric code' packaging, it may push back the deadline as the industry wants to get it postponed till next April 1. However, indications are that the ministry may give some more time to the pharma exporters, may be till January next year.

Another suggestion under 'active consideration' is limiting the barcode system only to tertiary packaging, instead of the current proposal for making it mandatory on primary, secondary, and tertiary packaging, sources said. Thus, it will be introduced in a phased manner. This will be another big relief for the industry, especially the small scale and medium scale units which, otherwise, would be incurring huge additional and unviable expenses.

The ministry, which has already issued notification for implementing the system, has put March 31 as the deadline to receive objections and suggestions from the industry in this regard. The ministry is expected to come out with the clarification on relaxing the norms or extending the deadline after going through the suggestions from the stakeholders.

A delegation of the Pharmexcil met the additional secretary in Department of Commerce, recently to convey the apprehensions of the industry and strongly pitched for some respite in the norms, it is learnt.

As the registration of clinical trials in the country has been picking up fast ever since registration of clinical trials was made mandatory by the DCGI from June 15, 2009, the Union Health Ministry has upgraded the Clinical Trial Registry of India (CTRI) with several new features.

The CTRI has incorporated new features on audit trial, submission of EC-DCGI approval documents, trial transfer, trial search, etc.

In the new software application, once a trial is registered, all fields would be automatically 'locked' except for 'Recruitment status of trial'. In case changes are desired to be made, request has to be sent to the CTRI, quoting CTRI registration number, indicating the field that is to be changed. Accordingly, only the desired field will be 'unlocked' and once changes have been incorporated, the field will again become 'locked'. Further, all these changes will be available for public view, under 'Modifications' when a trial is viewed in the public domain. Uploaded documents if any are not visible in the public domain, although registrant may be able to view it upon login to CTRI.

For pre-registered trials, all fields remain unlocked except for those trials where Ethics Committee and DCGI approvals have been obtained. Registrants are encouraged to upload any additional information according to the new data. However, these changes will also be visible in the public domain under 'Modifications.'

EC-DCGI approval documents may now be uploaded from the CTRI site itself ss per the upgraded version. The uploaded documents will not be visible in the public domain. It is now feasible to transfer a trial from one registrant to another, within a company or between companies. Besides, trials can be searched and viewed by using a single word search (keyword search) or specific field search (advanced search) or a layered search (trial search).

The Clinical Trial Registry of India was introduced by the government in July 2007 as part of its exercise to strictly regulate the clinical trial industry in the country. The National Institute of Medical Statistics (NIMS), an arm of the Indian Council for Medical Research (ICMR) was mandated with the responsibility of setting up and maintaining the CTRI.

Based on the experience of the pilot project, it was decided to implement a fresh well designed Web Hosted Clinical Trial Registry to meet the expectations of the various stakeholders including the pharmaceutical industry, researchers, publications, administrators and the public at large. Being a front runner, among the first 10 across the world, in the implementation of the mandate of registration of clinical trials, the Clinical Trial Registry of India is being keenly monitored across the world.

In order to weed out fake drugs from the market, the centre government's initiatives seem to be gathering momentum with many Indian pharmaceutical companies adopting SMS-based tracking facility to ensure genuineness of their medicines.

US-based PharmaSecure has reported greater acceptance of its track-andtrace facility in India. It is a leading global player in providing SMS-based authentication services to pharmaceutical manufacturers. The steps taken by the government to eliminate counterfeiting of drugs have yielded dividend so far. Recently, the government made it mandatory for all drugs being exported to carry serial numbers with track-and-trace capability. The notification to this effect was issued by the Directorate General of Foreign Trade (DGFT) to all pharma companies operating in the export market. The Drug Consultative Committee (DCC) of the ministry of health has also approved a unique identifier for all domestic drugs so that they can be verified by consumers through SMS, a path-breaking initiative taken in the best interest of millions of consumers in the nook and corner of the country.

PharmaSecure did not reveal the name of the clients citing confidentiality clauses. Previously, PharmaSecure had implemented this solution for major brands across India, including a 70-million packages coding contract from Unichem Laboratories. A section of pharmaceutical manufacturers are reportedly up in arms against the government's move stating that the new changes would necessitate major changes at their current manufacturing facilities and would lead to escalation of their costs. But service providers have downplayed such fears. India will be one of the few countries to have secured its supply chain for pharmaceutical products when fully implemented,. India is the third largest exporter in the world in terms of volume of drugs. Recently, fake medicines, allegedly made in India, were sold in some African countries creating a bad name for India.

The government has ruled out sharing test data of drugs, or data exclusivity, of Indian pharma firms with developed countries and multi-national companies, and stressed that the provision will not form part of any free trade agreements pursued by the country. The government stated that it will not provide data exclusivity because it "will prevent genuine and competing version of a drug from entering the market even when there is no patent as the patent has expired". Data exclusivity provides protection to the test data generated by pharma companies producing generic drugs. Commerce and industry minister Anand Sharma said that India does not provide data exclusivity for pharmaceuticals and agro-chemicals which is in the paramount interest of our generic pharmaceutical industry as grant of data exclusivity would have considerable impact in delaying the entry into the market of cheaper generic drugs.

Not meeting full mandatory disclosures of their patented medicines in India might cause pharma companies to invite penalties and, therefore, may result in domestic pharma firms selling low-cost version of their drugs. Many pharma MNCs, including Pfizer Roche and Bayer, come under the list.

It is mandatory for companies to share details such as if the patent is working in India, how much products are sold, whether it is manufactured locally or licensed and if the firm is able to adequately meet the requirements of the local market which is to ensure the patents granted in the country are being utilised for the benefit of patients.

Domestic generic drugmakers are prevented by patent holders from launching their cheaper versions by getting court injunctions even when their patent was not utilised in the country which is a violation of the local laws.

Bayer is fighting a patent case related to its drug Nexavar and the matter is sub judice but the firm reportedly complies with all the requirements of the Indian Patent law.

Hyderabad-based Natco has already initiated the process of seeking a compulsory licence to make and sell generic version of Bayer's Nexavar saying that the drug is too expensive for local patients.

In addition, the local patent authority can also penalise the patent holders with a fine of 10 lakh for non compliance with disclosure norms. Domestic drugmakers, health activists and patent holders are sharply divided over the local IP laws, its implementation and usage.

India adopted a new patent regime in 2005, thus patent-holders receive 20 years of exclusive marketing rights for their product in the country. In return, companies have to ensure patents are used to benefit local patients.

According to the Union Health Ministry there is no proposal under consideration of the Government to bring in amendment to the Drugs and Cosmetic Rules to make mandatory the registration of all brands of medicines by the manufacturers.

There were reports that the Government was considering a proposal to make it mandatory for the drug manufacturers to register all their brands, with a view to avoid duplication of brands in the market.

The Pharma Department reportedly held discussions with some industry associations on suggesting ways to regulate brands and one of the ideas emerged was the mandatory registration. However, the administrative ministry of the D&C Act is Health and it has now ruled out such a move.

The proposed idea of mandatory registration of brands has been under discussion for some time now, as the regulatory officials wanted to have a centralised database to streamline the process of issuing brand names. Even a direction in this regard had come from the Supreme Court a decade ago asking the regulatory authority to co-ordinate with the trade mark office, but no action could be initiated so far.

Sources with the ministry hold opinion that there were many common brand names by different companies in the pharmaceutical market and consumers were getting confused. Besides, companies also have variants of existing brand that are strikingly similar to a different product with a view to cash on the popularity of the successful brand names.

To bring out a report on a long-term policy for the pharma sector, an expert panel has been formed to give its report within three months of its first meeting. The task force comprises of representatives of the health ministry, the Department of Industrial Policy and Promotion, the National Pharmaceutical Pricing Authority, various drug industry bodies and business chambers. It is headed by V M Katoch, director general of Indian Council of Medical Research and secretary to Department of Health Research.

The panel would evolve policies and strategies to make India a hub for drug discovery and research and development. It has been told to recommend strategies to further the interests of the pharma industry in the light of issues related to intellectual property rights. It will also suggest steps to capitalise the opportunity of drugs worth $60 billion going off-patent over the next five years.

National drugs security is another focus area of the task force. It will find ways to promote indigenous production of bulk drugs, prevent takeover of Indian pharma companies by multinational companies, tackle problems of spurious drugs and promote generic drugs. The task force will also make recommendations on drug pricing.

Acquisitions of Indian pharma companies by many pharma MNCs has been the most pressing issue of the sector recently and the government seems to have taken a serious note of it.

In the wake of the fears being raised by Indian government as Western nations and big MNCs getting predatory towards domestic generic drug industry, the government is planning to regulate foreign investments in the sector, where 100% FDI is now allowed through the automatic route. As per the plan, FDI above 49%, if used to acquire stakes in Indian companies, would come under the scrutiny of the Foreign Investment Promotion Board (FIPB). FDI meant for greenfield ventures would, however, continue to be under the "automatic approval" route, where the Reserve Bank of India is the sole gatekeeper.

There have been six big-ticket acquisitions in the Indian pharma sector since 2006. The government reckons that the multinationals, which are hit by drying up of new drug pipelines, are attempting more such buys in India. The price to earnings ratio-the measure of price per share offered to the net income per share being offered by the pharma multi-nationals are two-to-three times the going rates in other industries.

The Indian pharma market (IPM), which is already worth $12 billion, is estimated to add another $40 billion to it in the next five years at a time when the annual growth rate in the developed market is around 1%; with scores of US-FDA approved plants in India, India could also be a manufacturing base for exports to the low-income countries.

Ernst & Young, which has been given the mandate to submit a report on the issue to the government, would likely build its arguments around the need to maintain 100% FDI in the segment, provided the government brings in enough riders to ensure the investment suits the domestic market and helps keep prices affordable to the masses.