Drug authority may require patent for approval of biosimilar drugs

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.

Asli Nakli

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’.

.. 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.