Patents in Medicines

• An expert committee on compulsory licensing has recommended that the department of industrial policy and promotion (DIPP) issue a compulsory licence for the manufacture of Bristol-Myers Squibb Co.’s anti-cancer drug Dasatinib to two companies
• It will be India’s second compulsory licence and a significant blow to the New York-based drug maker. A compulsory licence would allow the government to produce a generic version of the patented medicine and sell it at a cheaper price.
• In March 2012, India issued its first compulsory licence to Natco Pharma Ltd for the manufacture of Bayer AG’s Nexavar, another anti-cancer drug.
• Under the Indian patents Act, a compulsory licence for manufacture of a patented pharmaceutical product can be issued if the drug is considered unaffordable by the government.
• The World Trade Organization’s (WTO’s) TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement allows a country to issue a compulsory licence without the consent of the innovator if it is in public interest.
• In January 2013, the health ministry approached DIPP for issuance of compulsory licences for three anti-cancer drugs —Roche Holding AG’s breast cancer treatment Herceptin (Trastuzumab); and Bristol-Myers Squibb’s leukaemia medicine Sprycel (Dasatinib) and chemotherapy drug Ixempra (Ixabepilone). India’s patent office comes under the purview of DIPP.
• DIPP forwarded this request to the committee on compulsory licensing, which has reached a decision on all three drugs. A single 50ml vial of 40mg Trastuzumab costs Rs.1.24 lakh, a 45mg vial of Ixempra costs Rs.66,430.60 and 60 tablets of 20mg each of Dasatinib are priced at Rs.1.17 lakh.

Patents in India : Under protection or over protection

• The Indian Supreme Court, in a landmark judgment in April, turned down a request by the pharmaceutical company Novartis to retain the patent on a cancer drug because it judged the drug to be an extension of existing medications, not a groundbreaking advancement.
• In fact, a U.S. court invalidated a Pfizer patent covering a blood pressure medication (Norvasc) on grounds very similar to the Novartis decision, i.e. mere physical advantages cited for the salt form such as increased stability and solubility were not good enough to merit patent protection.
• Between 2005 and 2011, more than 4,000 patents for pharmaceutical inventions were issued by the Patent Office. Of these, more than 85 per cent were awarded to multinational drug companies.

 

Terms

Hepatitis B

• Individual Donor-Nucleic Acid Testing (ID-NAT) advanced screening technology.
• Doctors said that HBV, known as a “silent killer”, is more infectious than HIV and is the cause for liver cirrhosis, liver failure and liver cancer.
• Hepatitis (liver inflammation) occurs when the liver, in reaction to harmful elements (commonly drugs, alcohol and viruses), swells and slowly loses its ability to function.
• Hepatitis B Virus is not spread by contaminated food. It is transmitted through contact with blood or other body fluids of an infected person.

Assisted Reproductive Technology Bill

Introduction :

Surrogacy in commercial form is legal in India with the landmark Supreme Court judgment and later, the Indian Council of Medical Research (ICMR) Guidelines 2005 which prescribed conduct and use of ART procedures or treatment by fertility clinics. Subsequent to this the ART (Regulation) Bill 2010 was formulated by the Union Ministry of Health & Family Welfare, which is still awaiting enforcement. The ART Bill legalised commercial surrogacy by providing for payment as “monetary compensation” to the surrogate mother by the intending couple.

 

Critics :

1. There is no maximum age limit prescribed under the Bill for the couples or individual in order to be eligible to make use of ART though the minimum age limit is prescribed as 21 years.
2. There is no screening of the socio-economic/family background of the couples. Neither are there any eligibility criteria for an individual to be a fit parent to have child via surrogacy. There is no appointed government body to monitor the issue.
3. The ART Bill prohibits sex-selective surrogacy in consonance with the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act

Blood

Who can Donate Blood ? 

1. Anybody between 18-60 years of age.
2. Ensure a 3 month gap between donations.
3. Those who weigh over 45kg can donate 350 ml of blood and over 56kg can donate 450 ml of blood
4. Those who are HIV positive or have any STDs cannot donate blood.
5. Those suffering from high BP,heart diseases, or have a history of jaundice,tuberculosis,leprosy,hepatitis B/C are permanent deferrals and cannot donate blood.
6. Those who have unexplained weigh loss,swollen glands and continuous low grade fever are advised not to donate blood.
7. Time restrictions for those who have consumed antibiotics , steroids, alcohol or have undergone immunization before blood donation.
8. Pregnant,lactating and menstruating women cannot donate blood.