DRUG DICE: GENERIC, BRANDED etc

DRUG DICE: GENERIC, BRAND, ETHICAL, OTC, MONOPOLY & WHAT NOT!

DR ANIL BHADORIA, PRESIDENT-IMA, INDORE BRANCH, 23-24

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My professor of medicine used to say in our medicine subject class, that living a human life that too without a bacteria called Entamoeba infested In the Intestine is next to impossible in India. In the same way no Indian is seen now, not living without ingesting a chemical composition called Drugs or Medicine. The world is filled now with a variety of synthetic Medicinal preparations, be the food supplements, vitamins or minerals or anti symptomatic allopathic medication or chemotherapy drugs.

         Science has invented many life-saving drugs in the last century ranging from Penicillin, Paracetamol, Adrenalin and many hypoglycemic agents,  hypotensive drugs and disease-preventing vaccines. A big Pharmaceutical market of multiple Billions thrives on these products with natural or artificial or situational demand creation for very obvious reasons. These drug preparations are available in the form of pills, capsules, suppositories, injections, syrups, gels, drops, creams, emulsions, powder, sachet or in ampoules for particular health reasons to be taken through oral, nasal, rectal, topical or injectable routes. For early diagnosis Diagnostic reagents, contrast material, and stainers are essential and make a big industry. Many pharmaceutical products and chemical compositions are available in the market on an OTC basis i.e. Over The Counter, meaning no doctor’s prescription is required to purchase. On doctor’s prescription various schedule drugs are sold by retail drug outlets which are manufactured under various licences.

The structure of medicine selling at the retail point is so confusing that its cost-price ratio is ever variable for the same molecule. Drugs are available at medical shops in a variety of categories as Branded, Generic, Propaganda-cum-distribution(PDC), Over The Counter(OTC), Patented (Research Molecule), Monopoly (Sole Manufacturer), Ethical and so on and so forth. A common man cannot understand these many categories and the inside story of the drug industry. Ironically the price of the same drug molecule varies in a wide range in Brand, Ethical, Generic or other category when one purchases from a retail outlet. Some drugs are OTC drugs that are over-the-counter drugs which are available to end users on demand as no prescription is required. Food supplements, vitamins, certain common analgesics, disinfectants, drops, and powders are sold in this category. Our Prime Minister is putting all his efforts into economical and cheaper rates of drugs and advocating exclusively for enhanced usage of generic medicines. But any end user can ask what is the difference between generic brand or ethical Drug molecules. Is there a manufacturing compromise or difference in technology in making generic or brand molecules? Why Generic category drugs are cheaper in comparison to branded ones of the same molecule. Why do private sector doctors rely more on branded products in their Prescriptions of  Medicines? Why common man is not made available with generic molecules while he is admitted to a private or super-speciality or in a corporate hospital? Why there is an exorbitant difference in the pricing of generic category drugs and branded drugs? This is all to be answered by policymakers as this is confusing even to practising doctors. A Skeptic mindset is there when a doctor picks a pen up to generate a prescription. A thought process swirls to confuse a Doctor that branded molecules are quality products, as the manufacturing company has a turnover of several thousand crores or is a multinational or quality conscious or this molecule is their research molecule. This is also established that Multi-crore turnover companies also manufacture both generic as well as brand products with the same raw material for a drug molecule. Maybe even doctors have a notion that generic products are manufactured in a compromised way like a small drug manufacturer having a thin turnover who will never be that quality conscious. May be marketing drive of generic products is not prevalent or aggressive and therefore they remain cheap in pricing.  These are all more or less accepted myths. Facts are to be understood as all drug manufacturers have to undergo a rigorous licensing process, including WHO’s GMP certification, which enables the manufacturers to stick to advanced and ethical norms for producing drugs which are sold in Retail. Generic drugs are defined as manufactured drugs, which are similar in Dosage form, Safety, Strength, Route of administration, Quality, performance, Characteristics and intent of use to any ethical product. A generic drug is created to be the same as any marketed Brand-name drug. It is expected from all generic drug manufacturers to ensure an equal quality and bioavailability index and meet the same high standards of quality and manufacturing just like the brand name product. Generic medicine uses the same active ingredients and raw materials as any ethical or brand-name medicine manufacturer uses. The risk factors be it adverse and side effects of a brand and generic molecule are very similar. It’s also possible that a generic drug has certain minor differences from the brand name product. It’s important to understand that there will always be a slightly expected variability which is not medically significant, just as there is for one batch-lot of brand name medicine compared with the next batch-lot. This is for sure the branded one is the premium product just like any cloth of branded company and that too of clothes prepared in a powerloom.

The Government of India has a statutory body to control the pricing of drugs under Drug Prices Control Order 1995 under Section 3 of the Essential Commodities Act 1995 as drugs and essential commodities for health of the society. DPCO 2013 has 680 scheduled drug formulations spread across 27 therapeutic groups. NPPA Or National Pharma Pricing Authority 1997 is entrusted with the fixation and revision of prices of bulk drugs and formulations under Pharmaceutical products. As per provisions of DPCO 2013, drug prices are fixed as ceiling prices, which is first working out a simple average of PTR, that is Price To Retailer. The ceiling price is notified in the Gazette of India from time to time, normally exclusive of excise duty, local taxes and transportation. Non-schedule drugs are not required to take price approval from NPPA yet have to be monitored and take corrective measures when warranted. Schedule drug margin to a retailer is in the range of 8 – 16%. For non-scheduled drug, the margin is at the liberty of the manufacturer and are not under a Direct price control Order. Generic medicines cost less than their brand-name counterparts. Because they do not have to repeat Clinical Trials which are very much required for a research molecule by a Pharmaceutical manufacturer. To demonstrate Safety and effectiveness it is for sure, Research molecules have to spend a  lot of money on scientific processes and scientists for years together and therefore monopoly products or patented products cost a lot to manufacturers and are therefore priced higher to the end user. Generic products are out of the patent bracket and therefore multiple manufacturers are in a common market with a competitive edge of pricing which is beneficial to the end user. Multiple generic drugs are often approved for the same single product creating healthy competition in the marketplace therefore typically resulting in Lower prices of Generic Product of medicines.