Importance of this topic for coming 2013 PT
- Generally discoverer of a drug can claim patent rights for 20 years. After that generic drugs can be produced. Recently india used compulsory licensing for the first time in NEXAVAR case
- Recent Supreme court’s judgement in Glivec case.
- Januvet case is still going. So many times issue of generic drug and branded drug is arising. I tried to compile all informations relevant to them.
- Some illegal companies in the world are producing counterfeit drugs with “Made in India” title. [ recent example – few Chinese companies] Because India is the leader in generic medicine production. It creates bad name to Indian pharma industry. So how counterfeit drugs differs from generic drugs. lets follow the article…..
WHAT IS BRANDED DRUG
- It is the trade name the manufacturer gives to the medicine.
WHAT IS GENERIC DRUG
- Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.
WHAT IS THE DIFFERENCE BETWEEN RELEASING A DRUG WITH BRAND NAME AND A GENERIC NAME
- When a company discovers a drug à it gets patent right for 20 years [ This means that other pharmaceutical companies may not sell this substance without permission from the developing company during that time]. à it will also get brand name à then it will supply the drug in the market with the brand name à but branded drugs will be costlier because company invests heavily in research infrastructure
BUT WHY GENERIC DRUGS ARE CHEAPER THAN BRANDED DRUGS
- Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug.
- When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug.it is not the case with Generic drugs.
WHETHER EXPIRED PATENT RIGHT CAN BE RESTORED FOR THE BRAND DRUG
- No. once patent time period is over, anyone can use the mechanism to produce the drug but it must have the same chemical composition, same dosage form, at the same dose or concentration, and for the same route of administration as branded drug
WHAT IS COMPULSORY LICENSING
- The Government has recently decided to invoke the flexibility under the World Trade Organisation (WTO) agreement on trade related Intellectual Property Rights for compulsory licensing of patented drugs to ensure availability of patented drugs at affordable prices. In essence, under compulsory license, an individual or company seeking to use a patent can do so without seeking the patent holder’s consent, and pays the patent holder a set fee for the license.
- Recently India used the Compulsory licensing provision of WHO to make Generic version of NEXAVAR, an anticancer drug. Because it was costlier so poor are dying of cancer without the ability to buy anti-cancer drugs.
ARE GENERIC DRUGS INFERIOR TO BRANDED DRUGS IN TERMS OF QUALITY
- The generic drug may differ from branded drug terms of in color, shape, taste, inactive ingredients, preservatives and packaging
- Generic drugs should prove that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product.
- Additionally, the generic needs to meet pharmacokinetic parameters in the body, which means e
WHAT IS COUNTERFEIT DRUG
- A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness.
- A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body (e.g., absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labeling
HOW GENERIC DRUG IS DIFFERENT FROM COUNTERFEIT DRUG
- Generic drug has the same chemical composition as branded drug whereas Counterfeit drugs may have low low quality drugs or may have some unnecessary drugs
- Generic medicines are produced LEGALLY after the expiry of 20 years of patent registration [ for brand drug]. But Counterfeit drugs are produced in the name of generic medicine. Because it gives more profit
WHY THERE IS A NEED FOR GLOBAL TREATY TO CONTROL COUNTERFEIT DRUGS
- India’s generic medicine industry frequently affected by counterfeit drugs. Because there is no global criteria to define counterfeit drugs. So global treaty on fake drugs becomes necessary.
- Although some countries prohibit fake medicines under national law, there is no global treaty which means organised criminals can continue to trade using haven countries where laws are lax or absent. [ similar to tax heaven nations in case of economics]
OECD REPORT ON FAKE MEDICINE
- According to a report released by the Organisation for Economic Co-operation and Development (OECD), 75% of fake drugs supplied world over have some origins in India, followed by 7% from Egypt and 6% from China
ADVERSE EFFECTS OF COUNTERFEIT DRUGS
- In richer countries, medicine safety is better, but substandard and falsified drugs still cause thousands of adverse reactions and some deaths.
- Recently, in the US, contaminated drug supplies caused an outbreak of meningitis that has so far killed 16 people
POLITICS OF COUNTERFEIT MEDICINE
- Few months back, counterfeit drugs were captured in England. These drugs had “made In India” tag. But india denied that. According to political thinkers, they might have produced in China with Made in India to destroy india’s vast pharmaceutical sector
- According to Indian pharmaceutical sector, Western countries are trying to restrict the growth of India’s Generic medicine industry by creating unnecessary delays in the name of counterfeit drugs.
GOVERNMENT’S RECENT INITIATIVE
- In its biggest move to push generic drugs and do away with brand names, the Union health ministry has ordered states to stop issuing licence for the manufacture or sale of drugs on the basis of their brand name.
- All pharmaceutical firms applying for licence to market or manufacture fixed dose combination ( FDC) drugs will have to submit their generic name and not as brands with immediate effect
- The ministry has been going all out to promote generic medicines. It has made mandatory for all doctors in the public sector to prescribe generic drugs and not brands. Doctors have warned that strong action will be taken against doctors found prescribing brands.
JAN AUSHADHI CAMPAIGN
- The Department of Pharmaceuticals has also launched a country wide campaign in the name of ‘Jan Aushadhi Campaign’ in collaboration with the State Governments by way of opening of Jan Aushadhi Generic Drug Stores in the Government Hospitals and supply of medicines through Central Pharma PSUs
- A countrywide chain of medical stores called as Jan Aushadhi, to make generic and other drugs available at reasonable prices.
INITIATIVE OF HEALTH MINISTRY
- The health ministry is also gearing up to make “Free medicine for all through Public Health Facilities” in all government health facilities a reality soon.
REPORT OF NATIONAL SAMPLE SURVEY ORGANIZATION [ NSSO]
- In many states, people spent highest out-of-pocket expenditure on drugs
- The sharp increase in prices of drugs has been the main reason for the rising costs of healthcare, which more than tripled between 1993-94 and 2006-07.
EFFECT OF DOING AWAY WITH BRAND NAMES
- Government ordered to sell medicine in the name of chemical name and to avoid brand name
- The move will substantially reduce medicines’ prices.
- For example, Crocin will cease to exist, and it will be marketed and sold as paracetamol.
- A branded drug can be 10 times more expensive than a generic variant.
PARLIAMENTARY STANDING COMMITTEE REPORT ON BRAND DRUGS
- The parliamentary standing committee in its recent scathing report had also expressed strong objection to the practice of issuing licences on brand names.
SECTION 33P OF THE DRUGS AND COSMETICS ACT, 1940
- It grant / renew licenses to manufacture for sale or for distribution of drugs in proper / generic names only.
AMENDMENT TO DRUGS AND COSMETICS RULES, 1945
- Amendment to Drugs & Cosmetics Rules, 1945 allows issuance of licenses of single ingredient drugs in generic / proper names only.
ROLE OF NPPA
- National Pharmaceuticals Pricing Authority (NPPA) under the Department of Pharmaceuticals also monitors and regularly examines the movement in prices of non-scheduled formulations.