The Hind Business Line reports that the Drug Regulatory Authority in India is “considering a proposal wherein generic versions of bio drugs, called biosimilars, may be mandated to apply for patents.”

Biopharmaceutical drugs are medicines produced using a living system or genetically modified organism. Compared to traditional chemical medicines, even a minor change in the conditions, formulation or the processes can change the final product drastically.

Biosimilar medicines are supposed to be replicate versions of original biopharmaceutical medicines designed to treat the same diseases as the innovator’s product. However, compared to generic versions of chemistry based medicines, biosimilar medicines are extremely complex.

The report quotes the Director General of the pressure group ‘Organisation of Pharmaceutical Producers of India’ (which counts among its members several “Big” pharma companies like Pfizer, Eli Lily, Roche and GSK, significantly excluding generic biggies like Cipla and DRL) as approving this idea because of “the complexities involved,”

The very nature of a biologic means it is practically impossible for two different manufacturers to produce two identical biopharmaceuticals if identical host expression systems, processes and equivalent technologies are not used. This has to be demonstrated in an extensive comparability programme. Therefore, a generic biopharmaceutical cannot exist.”

A “Government source” however said that a final view is yet to be taken.

According to Mr. Ray only such stringent measures can facilitate the growth of the biogeneric business.

Ha.

Some interesting articles in the papers this last week.

Latha Jishnu’s written a characteristically insightful and analytical piece about GI registration in India. Excerpts:

In recent months there has been practically a stampede for GI registration in India. Unlike the developed countries which use it primarily for food products (Champagne, of course, and things like Parma Ham), India has extended GI protection to products across the spectrum, from handicrafts to flowers and spices. Thus the Aranmula mirror, along with assorted silks, saris, textiles and embroidery styles, joins soaps, incense, different varieties of jasmines, several strains of rice, tea, betel leaf, pepper and chillies to get the GI tag.

The GI Registry at Chennai, where right-holders can register their products, is getting inundated. The question, however, is how much of a protection a GI offers. For one, other WTO members are not obliged to ensure the same kind of protection to all Indian GIs because there is a problem of hierarchy. Although TRIPS has a single definition for all GIs, it has authorised a two-level system of protection: one, a general protection under Article 22, and the other, a higher level under Article 23 that is applicable only to wines and spirits.

According to some experts, Article 22 is not good enough. It is simply a law against unfair trade practices and for consumer protection and is not really for IPR protection. A producer not belonging to a specific geographical region could still use the GI as long as the product’s true origin is indicated on the label. In other words, an Aranmula mirror could be turned out from, say, Houston in Texas, thus allowing an American producer to free ride on the reputation and market goodwill created by Keralite artisans over two centuries. Tellicherry pepper and Udupi jasmine thus far are not in the same class as wine from Champagne.

Lawrence Liang’s article in the Indian Express covers the recent Rakesh Roshan V Ram Sampath row in the Bombay High Court and makes some poignant comments on creativity, copying and copyright.

The language of the case and the reportage around it rely very heavily on the language of theft, property and damages for infringement of copyright and plagiarism in music. This rather hasty leap of faith to stricter enforcement of music copyright does not seem to find too much support in the history of music itself. While there was surely a violation of propriety in the Ram Sampath case, the important question that emerges is the impact of thinking of creativity only in terms of property. The history of copying, appropriation and plagiarism is in fact central to the history of various forms of cultural production, including music. We should therefore be a little cautious when we celebrate this case for the quick remedy it provided to an act of copying.

The act of copying has been central to the ways in which culture has flowed through various parts of the world, transcending the limitations set by space and time. Thus a Polish folk song, “Szla dzieweczka do gajeczka”, becomes a part of Indian popular consciousness through its adaptation as Salil Chaudhury’s “Dil Tadap Tadap Ke” from Madhumati. Secondly, the creation of music has always relied on adaptations, influences and inspirations, whether conscious or unconscious. It would be unfortunate if as a result of aggressive copyright suits, we reach a situation like the United States where even subconscious copying is held to be infringement. In a case brought by a band, The Chiffons, against former Beatle George Harrison, the court held that Harrison’s “My Sweet Lord” was in infringement of The Chiffons’ “He’s so fine”, even though the judge believed that Harrison did not intentionally copy the song and had only been inspired by it subconsciously.

In our enthusiasm to protect the creator and ensure that he gets his just rewards, let’s not forget that the sense of touch is not limited to the hand, but extends to our eyes and ears. It is only natural that when we create something, it will be influenced by things we have read, heard or seen, even if they are not our property. Walter Benjamin describes this form of mimicry as a form of learning as a “sensuous similarity”, a right to copy, which should be as jealously guarded as copyright.

The Hindu Business Line reports today that “the Department of Telecom has asked telecom operators not to provide certain features offered by Research In Motion’s (RIM) BlackBerry until monitoring systems are put in place.” It is not known what “certain” features are exactly, but “industry sources indicated that e-mails sent from one Blackberry to another Blackberry may be barred.”

Gee.. Emails huh? That’s all? Waittaminute.. isn’t that all one does with a Blackberry!?

Currently, talks are on directly between Research In Motion - owners of the Blackberry technology and the DoT after ‘GSM operators opted out of Blackberry talks‘

At a meeting held last week, RIM requested that it be allowed to discuss its plans to address the security concerns directly with Government authorities instead of going through the mobile operators. Sources said that RIM officials were concerned that since the topic of discussion was sensitive for security purposes, the proceedings of the meeting may be leaked out to the media in case the operators were also involved. While representatives of the various mobile operators were present during the meeting last week, RIM executives and DoT officers met separately in another room.
..

Sources within the GSM camp said that with only 2 lakh Blackberry users, there is no crisis even if the service was banned. They also pointed out that there were many other handset devices available today which provides similar type of services though the security levels may not match up to that of a Blackberry.

So.. what’s the big fuss about again?

Business Standard today carries this slightly unclear piece about a new Bangladeshi law that will increase “chances of technical partnerships in Bangladesh”. Apparently, Bangladesh has “changed its patent law in an attempt to become a hub for manufacturing cheap copies of patent-protected medicines. ” However, another statement in the same article casts some shadow on this assertion:

Nazmul Ahsan, general secretary, Bangladesh Association of Pharmaceutical Industry (BAPI):

“Our government is actively considering various provisions to incorporate the flexibilities of TRIPS (trade-related intellectual property rights) within the patent law. It will be in the form of annexes that make production of medicines having patent protection elsewhere legally possible. We will be able to supply it to other developing nations also,” he said.

The article contains the usual info about the TRIPs, parallel imports and developing countries as well as some useful info on how the Indian pharmaceutical industry operates:

India, under its new patent regime, cannot supply raw materials or bulk drugs of patented medicines. However, it can supply intermediates (which are one step down in the manufacturing cycle of bulk drugs) anywhere in the world.

If Indian companies can strengthen the technological capabilities of their Bangladesh partners, these intermediates can be further developed into bulk drugs and finished medicines in that country. While these medicines have an assured market in all poor countries, they can also reach nations like India on the basis of compulsory licences.

“Indian bulk drug companies are going to fetch good business as penultimate raw material suppliers to bulk drug firms in Bangladesh. It will be definitely attractive for all new products that cannot be made in India,” he said.

So.. we can’t directly infringe patents and manufacture drugs. So we will manufacture them cheaply till their last step. Export them over the border to Bangladesh where they are assembled. Then use compulsory licensing to re-import drugs back to India. A pirate alliance like no other! Everyone’s happy.

Bangladesh shouldn’t be happy with this arrangement. A couple of months ago, Padma Gehl-Sampath made a presentation at the Alternative Law Forum on the technical capacity of the Bangladesh pharmaceutical industry. According to her, although the industry has a fairly robust manufacturing base, it has a very thin research base due to inadequate investment in pharmaceutical education. So Bangladesh imports machinery to manufacture drugs, but does not itself possess enough skilled manpower to reverse engineer drugs. India’s pharmaceutical industry ‘miracle’ since the 70s has owed itself to the fact that we had a largish base of skilled pharmacologists who could re-engineer very quickly.

So, short term, as an Indian, this makes me very proud. Long term, I’d like to see more pirate drug producing nations.

A piece in the Hindu today about the ‘piracy menace’ presents an interesting glimpse into the informality of the networks within which ‘pirates’ operate.

“Sir, it is three-in-one,” said Rasheed, displaying about 100 DVDs in a compartment of the Mumbai–Kanyakumari Express. The the ‘three-in-one’ comprised Mammootty’s Roudram, Mohanlal’s College Kumaran and Suresh Gopi’s Sound of the Boot.

Contrary to claims made by the film industry, pirated VCDs and DVDs sell like hot cakes in the market. The piracy lobby is exploring all possible routes to boost sales. Like Rasheed, hundreds of youngsters are employed to market these DVDs in trains, bus stations and temporary outlets.

I cannot imagine Sony selling original DVDs on trains. A second class train ticket from Hyderabad to Bangalore costs just over Rs.250. By contrast, an original CD/DVD of a mainstram Hollywood film can cost between Rs. 400-600. No market analysis would ever recommend second class passengers as a target consumer group to focus on. And yet in audacious opposition to market analysis, the ‘pirates’ are making good business here.

On a reference from the Ministry of Information and Broadcasting, the TRAI has issued a consultation paper on “Policy guidelines for Television Audience Measurement (TAM) and Television Rating Points (TRPs)”.

Excerpts from the paper:

Television Audience Measurement (TAM)/ Television Rating Points (TRPs) have been in existence in India since 1993. Largely of interest to advertisers, broadcasters and media agencies who invest substantial amounts based on the ratings services; they have come up for greater public scrutiny only now; although concerns about their reliability had been expressed earlier as well. The advertisers’ decisions, programme scheduling and even programs available to the public are all affected by the ratings based on a small sample. Viewer’s likes and dislikes and interests largely remain unaddressed. Given the implications on scope, schedule and even content of programmes, the larger perspective of audience cannot be ignored. The impact of the visual media and its ever increasing reach and significant amounts riding on it, has necessitated a re-look at the issues like reliability, comprehensiveness and accountability of ratings.

Reliability of audience measurement reports both from the perspective of viewers and competitive relations between broadcasters have been of concern to the Regulators in most countries. Internationally, countries have largely come up with self-governing, not-for-profit institutions drawing membership from both advertisers and broadcasters that are responsible for, inter- alia, administering a reliable system of accreditation for broadcast audience measurement services. Ratings agencies are not allowed to be members of such bodies. Should this model be followed in our country as well; should there be an oversight body or should the TRP ratings and rating agencies be governed by some Standards prescribed and monitored by the regulating bodies?

The following issues have been raised for consultation:

5.1 Looking at the impact of Television Rating Points (TRP) on broadcasters, advertising agencies and advertisers, the first and foremost issue that arises for consultation is whether there is at all a need for the Government to regulate the system of Television Rating Points (TRP), or whether this should be left to be decided by industry initiative for the growth of the rating services? Please give reasons in support of your reply.
5.2 If it is felt that Governmental regulation is necessary, what should be the manner and extent of such regulation i.e. whether the rating agencies and or Oversight Bodies be subjected to light supervision or should they be brought under compulsory reporting obligations? Should it be a simple registration or any other mechanism? Please give suggestions on following issues, among others:
5.2.1 The eligibility criterion for registration in terms of technical capability/experience,
5.2.2 The minimum sample size (in terms of numbers) adequately representing various genre, regions, platforms, stratum etc. ensuring robust television viewing estimate;
5.2.3 Type of equipment to be used to address the different delivery platforms.
5.2.4 Whether technology adopted should be real time system for generation of reports;
5.2.5 Minimum coverage required a) over different platforms, b) rural and urban, c) All states including North-East and J&K, d) Prasar Bharati channels;
5.2.6 What are your views on restrictions on crossholding / interests between the Ratings Agencies and their clients?
5.2.7 What safeguards should be provided to ensure secrecy of sampled families? Please give your suggestions.
5.2.8 Whether some standards/norms be prescribed for the rating agencies that should be followed for their operations? If so, what should be those standards/norms?
5.2.9 What are your views on mandatory audits to be performed by independent auditors for validation of ratings provided by rating agencies? What should be their qualifications? What should be the scope of such audit, and who should the auditors report to?
5.3 If it is felt that this should be left to be decided by industry initiative, what should be the framework for such arrangement and the role of the Government with reference to the issues narrated from 5.2.1 to 5.2.9.
5.4 What are your suggestions to encourage competition in rating services?
5.5 Do you have any other suggestions for making ratings more representative, transparent and reliable?

Comments are due before 21 April 2008.

The DoT on Friday has reportedly given two weeks to Research in Mobile (RIM) - the company that has developed Blackberry - to install servers and requisite equipment in India in order to tap e-mails sent through the service.

This was the message conveyed to the RIM representative in the country at a high level meeting in the department of telecommunications (DoT), which was chaired by the deputy director general (access services).

Officials from the ministry of home and representatives of Airtel, Vodafone, Reliance and Blackberry were also present in the meeting. The deadline for setting up this facility will be decided in a meeting scheduled next week, when high level officials of RIM from Canada will be present.

And also

RIM is currently operating services in 13 countries around the world. The present problem with Blackberry came to limelight when Tata Teleservices was not granted permission to operate the services. The government said that it was not possible to lawfully intercept e-mails sent through Blackberry phones. It is not yet clear how other operators like Reliance, Airtel and Vodafone are operating the services.

It is not clear. Not clear at all. The DoT website does not list any of these three as having obtained a UMS license. Does the ISP license imply a UMS license? Clearly not - since a UMS license requires a licensee to obtain, in addition, an ISP license.

So what happens next?More meetings.

Another meeting with RIM officials has been scheduled next week to discuss the issue further. In today’s meeting only a local sales representative of the company was present. “These are high level technical issues and hence the DoT officials today asked RIM representative to bring senior technical officials from Canada preferably by 2nd or 3rd of April for the next meeting,” said the industry representative.

Just parking this news item from the Hindu

KOCHI: Malabar Monsooned coffee, a speciality item from the northern Kerala coast, which had conquered the palates of the western world is all set to achieve another landmark when the Geographical Indicator (GI) status would be conferred on it soon.

The Coffee Board officials have already conducted a couple of sittings and it is a matter of time before GI status is given to ‘Malabar Monsooned’ coffee, sources in Aspinwall & Co, which has a market share of nearly 50 per cent of this export commodity, told The Hindu here on Thursday.

This speciality coffee has an interesting genesis, and is cured by the unique monsoon rains of the Malabar coast. What makes it stand apart from its peers is definitive characteristics such as ‘good body, mild acidity, pleasant aroma and flavour.’

A much-sought after item in the Scandinavian countries, with a smattering of followers in Germany, the coffee has many ‘pretenders’ who copycat its qualities mainly in Italy and in the Indonesian coffee production centres.

Reading the tea leaves,

Producers in northern Kerala and the south Karnataka region mainly hope that the attainment of GI status would usher in a premium to the product that could help in withstanding the volatile fluctuations in the international coffee markets.

Malabar Monsooned has an interesting history.

During the olden days, when coffee from the Malabar coast were transported in sailing ships, the damp environment in the wooden holds of the ships significantly altered the physiological nature of the beans.

The coffee beans lost is colour and quality within the six-month period of journey in the sailing ships.

However the consumers in the West, developed a taste for the coffee that was mellow and less acidic. They started complaining about the taste when the coffee was later shipped in the good holds of the steam ships. .

© Copyright 2000 - 2008 The Hindu

There’s been a slew of interesting OriginalFake court rulings over the last few days:

• The Supreme Court has held that only licensed allopathic manufacturers can sell Viagra.. The accused were engaged in the manufacture of supposedly Ayurvedic Ozomen capsules and Ozomen forte which contained quantities of “sildenafil citrate” - one of the primary ingredients of Viagra. Section 18(a) (i) read with Section 17B(d) of the Drugs and Cosmetics Act prohibits manufacture and sale of certain drugs and cosmetics which are ‘misbranded, spurious and substituted wholly or in part by another drug or substance’.

The AP High Court had quashed the proceedings holding that the Drugs Inspector appointed under Section 21 of the Drugs and Cosmetics Act had no jurisdiction to launch prosecution under Section 32 of the Act (which deals with offences pertaining to Ayurvedic drugs).The Supreme Court held that this was not a case of an Ayurvedic drug, but clearly one involving an allopathic drug which was sought to be passed off as Ayurvedic.

• In M/S PARAKH FOODS LTD v. STATE OF A.P. & ANR, the Supreme Court held that a company cannot be blamed and found guilty of misbranding a food article if the picture on its label has nothing to do with the food article concerned. From the Indian Express news report:

The product in question was soyabean oil and the label, as noticed by the High Court, contained pictures of vegetables like cabbage, carrot, brinjal, capsicum, cauliflower, tomato and onions, which it found “are in no way connected with soyabean oil”.

While the High Court held that this was a case of misbranding, the Supreme Court took an opposite view

“In our opinion, the High Court has committed a serious error in arriving at a finding that the article of food (soyabean oil) was misbranded, since the picture contained on the label has nothing to do with the article of food in question, ignoring the fact that the article of food can be used for cooking the vegetables shown in the picture which cannot be said to be exaggerating the quality of the food in question.”

• The third case involves the advertisements of a pain balm called Volini manufactured by Ranbaxy which was accused of disparaging its rivals. Business Standard reports:
  

  The Supreme Court today directed Ranbaxy Laboratories to drop the word asli from its advertisement for Volini pain balm but allowed it to run the rest on television despite the protest of the manufacturers of a rival product, Moov.

  The Gujarat High Court had prevented Ranbaxy from running the advertisement which said that its product gives asli aaram while another product shown in purple is thrust away.
  Paras Pharmaceuticals, manufacturers of Moov, sued Ranbaxy for disparaging its product. The high court granted an injunction against Ranbaxy. Harish Salve, counsel for Ranbaxy, argued that hyperbole is allowed in a market which is not for the ‘faint-hearted’.

From the Hindu, the Chairman of the National Biodiversity Authority, Mr. S. Kannaiyan has announced the initiation of steps to create “a Biodiversity Information System, a meta database of biodiversity and bio-resources in the country”

The Union Government has allotted Rs. 10 crore for carrying out a pilot project in this regard.

The system will link all the databases and information sources related to bio-diversity and bio-resources including plant, animal, marine and microbial resources in various parts of the country.

Research scientists, policy makers and common man will be able to get information at a single point after the creation of the system.