.. more counterfeit drugs

Proving that all industry-wide bodies are alike in their megalomania, Assocham today disclosed estimates of “counterfeit drugs’ that are eerily similar to piracy scorecards the MPAA periodically puts out. Business Standard carries this article today with the heading “Fake drugs growing at 20-25%: Assocham”, and alleges that the fake and spurious drug market “has already exceeded the Rs 15,000-crore per annum mark nationally.”

The chamber also pointed out that the sale of spurious drugs in the National Capital Region (NCR) is to the extent of Rs 300 crore per annum, and according to the latest information available, it has gone up to 20-25 per cent of the total medicines sold in the region.

Intensification of the sale of spurious drugs in the region has not only severely impacted business of original drug manufacturers in the region by over 25 per cent but is also putting the life of patients on risk, the chamber said.

The concentration of fake drugs manufacturing facilities can be found in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and parts of Punjab which are closed to the NCR, it added.

The shortage of drug inspectors and proper lab facilities for checking purity of drugs and inherent weakness in drug distribution system are the main reason for the spread of fake drugs in the NCR, the chamber pointed out.”

Only last month, the Orissa High Court had reportedly observed : “Orissa has become a dumping ground of fake medicines” and had directed the State Government to check entry of fake drugs into the State from outside.” The court made this observation in a case pertaining to the death of five persons, including two newborns at SCB Medical College and Hospital, seven years ago allegedly due to spurious saline administered on them.

More grist for the Indian Drug-Scene jigsaw that I’m trying to piece together.

Sui Generis protection for Traditional Medicine

I picked up an interesting snippet of information from the Business Standard yesterday.

“The government may take back its earlier plan to provide five-year data protection to traditional systems of medicine.”

Stop press! The Government had a plan to provide five-year data protection to traditional systems of medicine?! Who knew!

We’re informed of some of the history about this startling plan in the article:

The government’s plans for data protection began after a high-level inter-ministerial committee, set up by the Department of Chemicals and Petrochemicals in 2004, favoured such protection for traditional medicines and agro-chemicals.
After considering the Department of AYUSH’s submission, the committee, in its report submitted in May 2007, recommended that irrespective of the nature or the period of data protection granted to pharmaceuticals in general, a five-year data protection should be provided for traditional medicines. (See Satwant Reddy Report)

It also wanted the health ministry to make amendments to the Drugs and Cosmetics Rules, 1945, to effect the change.

But not anymore. Evidently someone at the Department of Ayurveda, Yoga, Unani, Siddha and Homoeopathy (AYUSH) decided that “such a protection will lead to similar demands from the allopathic segment” .. who are already beneficiaries of the stronger Patent system.. ahem.. one could possibly argue.

More:

While the government has been supporting the move to introduce data protection for traditional medicines, it has been reluctant to offer similar protection to the pharmaceutical sector in general due to the concerns of the domestic drug industry.

Domestic manufacturers say “data protection”, which results in “non-reliance” of data generated by the patent-holding company, will increase the cost of drug production and delay the entry of generic drugs into the domestic market.

“There are serious concerns relating to the ever-greening of patents under the guise of data protection and the need for providing affordable drugs to people,” it had reasoned.

Data protection to pharmaceuticals has been one of the most debated issues due to the strong reservations expressed by the domestic drug industry against such a move.

On the other hand, multinational drug majors have been saying that data protection is a prerequisite for foreign investments in drug research in India.

While the committee recommended a five-year data protection for traditional medicines, it refrained from making such a recommendation for other pharmaceutical products.

I fail to see how one has anything to do with the other, Data exclusivity for drug test results and data protection for traditional medicines. It’s like blocking the passage of the Copyright Act on grounds that artists could conceivably demand Patent type rights.

But I support the outcome.

From every angle that you approach it, a plan to gift monopolies over traditional medicine appears ill-conceived. Such a move is likely to discourage existing traditional practitioners and healers from experimentation and improvisation. Instead it sounds like it may benefit most the very pharmaceutical companies who are engaged in the sort of bio-piracy we witnessed with the turmeric cases. Pharmaceutical companies do not need further incentives to research traditional medicines.. it’s research that’s already been done for them over millennia.

While proper benefit sharing mechanisms need to be put in place to ensure that communities can receive their rightful share from commercial exploitations of their traditional knowledge, the answer cannot be an expansion of the already inflated IP System. The answer to the Question of the IP commons, does not lie in the creation of more property.