Prices of life-saving medicines to come down

Last month, the chemicals and fertilisers ministry led by Ramvilas Paswan proposed a reduction of taxes on life-saving medicines on the assurance of drug makers that this benefit would be passed on to the consumers entirely.

The prices of about 20 life-saving medicines used in the treatment of diseases like cancer, diabetes and AIDS may go down in the coming months if the finance ministry considers the proposals for duty exemption on such drugs.

Multinational drug firms like Eli Lilly, Bristol Myers Squibb and Pfizer are likely to be the beneficiaries if the proposals find space in the forthcoming Union Budget.

According to sources, most of the imported medicines currently attract 10 per cent basic Customs duty and 16 per cent countervailing duty.

The recommended medicines are used in the treatment of diseases like diabetes, cancer, AIDS and asthma. A couple of preventive therapies like Hepatitis-B and pneumococcal vaccines also figure in the list.

Need to examine this some more. As usual this is a placeholder article.

.. 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.

Drugs

My Icommons article this month deals somewhat inadequately with the issue of access to medicine in the context of drug manufacturing in India. I say ‘inadequately’ because in the course of my daily news-trawlings I come across a diverse range of articles dealing with ‘counterfeit drugs’ and ‘drug rackets’ that are obliquely, but not directly pertinent to the issue of access to medicine.

While I’m dimly aware of there being some connection between International Taxation Laws, Intellectual Property and access to medicine, I’m going to use this article as a placeholder for interesting news clippings until I am able to understand the full significance.

So my newsletter today has two articles that report incidents of confiscation of Ketamine Hydrochloride – a veterinary anaesthetic that is also used as a party drug. Some 10kgs were recovered from a courier package in Chennai and another 25kgs from a passenger travelling to Singapore. The articles mention a significant price differential between the cost of manufacture in India and the drugs’ international sale price.

Last month (Jan 16th?), several leading pharmaceutical companies in the EU were raided by European regulators “in an inquiry into whether they conspired to keep up the price of drugs after patents expired.”
About time too, I think, since I’ve encountered news articles describing “delayed launch” deals between pharma majors and generic companies that have an eerily familiar ring to them. For instance, in the past few months, three generic manufacturers – Sun Pharma, Watson and Dr. Reddy’s Labs – entered into agreements with Novartis to delay “until sometime prior to the expiration of the patents” the launch of their variants of the drug Exelon – used for the treatment of Alzheimer’s disease . In return Novartis would abandon patent litigation that had been instituted against each of them.

Over the past few months, there have been three e-pharmacy related crackdowns reported in the news.

In September a person of Indian origin was convicted for selling Viagra and other drugs illegally in the UK in what is described as “UK’s biggest fake drug racket”. From the news report

Ashish Halai, 33, masterminded the multimillion-pound movement of fake Viagra and other lucrative drugs from factories in China, India and Pakistan into the UK and then on to the Bahamas and the US.

It is unclear whether these were ‘fake’ drugs because they were ineffective or because they were unauthorised reproductions. The MHRA press briefing on the case mentions that the accused were charged with offences relating to Trade Name fraud.

In a second incident, less than a fortnight ago, a joint Indo-US initiative unearthed an “online drug racket” with its operations based in Tamil Nadu. Excerpts from the news report:

Under the joint Indo-US initiative called Operation Cyber chase, the US Drug Enforcement Administration tipped off the Narcotics Control Bureau (NCB), resulting in busting of an online drug racket that has spread its tentacles to Coimbatore in western Tamil Nadu.

The three drugs, Alprazolam, Atrivan and Nitrosun, categorised as anxiolytic drugs, are prescribed for mentally stressed patients to reduce anxiety

A strip of 10 0.2mg Alprazolam tablets costs a mere Rs 7.50 in India, in the US, the over-the-counter cost is an exorbitant $US 125 for 60 tablets

Ramakrishnan traded in drugs that come under Schedule I of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, prohibited from export.

The company did not have the necessary licence either to export the drugs, having registered with the RBI for trading in consumer items alone.

Lastly, the Sanjay Kedia case sometime back involved a person allegedly arranging for the supply of the drugs phentermine and butalbital through a website called “TRUEVALUEPRESCRIPTIONS.COM”. The petitioner’s plea that he was merely a network intermediary, and so immune from prosecution under the IT Act was rejected by the Supreme Court.

The final news clipping in this series describes a fraud committed by two Indian drug firms “duped World Bank and Govt despite layers of checks“.

For seven years, between 1997 and 2004, two pharmaceutical companies, according to the World Bank’s review, sabotaged an elaborate system of checks and balances of both the Government of India as well as the World Bank. Not just in one healthcare project but three — spanning across reproductive health, control of TB and malaria. Ironically, these two companies secured contracts although they had been debarred by the Government in another health scheme — a fact that remained undetected.

Update
20 Mar 2008: 5 kg of ketamine hydrochloride worth Rs. 50 lakhs siezed from a Kuala Lumpur-bound, 23-year-old passenger