GENERIC MEDICINES: AVAILABILITY

A generic drug is equivalent to its brand name counterpart, but is usually much less expensive. A generic drug must have the same active ingredients, route of administration, dosage form, strength, and indications as the original brand product. The generic drug may differ from the original in non-essential characteristics such as color, taste and packaging. Generic drugs are deemed to be as safe and effective as the brand name product. Generics cannot be sold until after the drug patent expires on the original brand name product. Patents typically expire 20 years from the date of filing. During this period of patent protection, only the original manufacturer can research, develop and sell the brand name drug. When the patent expires, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market the generic version.

Generic drugs have lower research costs and increased market competition and those substantial savings are passed on to the patient. However, generic drugs still must meet strict FDA requirements with respect to quality, performance, labeling, manufacturing, and bioequivalence. By law, generic drugs must have the same active ingredients as the brand name product, and they can be expected to have the same effect when used in place of a brand name drug.

India may be famous for its generic drugs but patients seeking medicines like rifampicin (Tuberculosis or TB,) lamivudine (HIV/AIDS,) artemisinin (Malaria,) oxytocin (Reproductive Health,) fluoxetine (Mental Health,) and metformin (Diabetes) may not find generic drugs (having no brands) easily in shops across the country. The price of branded ones available is prohibitive, and not affordable to the common man.

This is the gist of a study published in the latest edition of the Journal of Global Health that looked at the availability of essential six medicines, in 124 private pharmacies across the state, including Mumcai. The study done by researchers at Newcastle University in UK and in Mumbai, found that the policy to open up the market has generated a large number of medicines, but there are still not enough availability in pharmacies.

“There has n’t been adequate governmental intervention with regard to sales practices by pharmaceutical companies. The Hathi Committee had years back recommended that medicine strips mention the generic names in big and in bold print and brand names in smaller print, but this recommendation has not been implememted.” Pure generic versions of drugs are not available in most cities.

It is the bounden duty of the government and the medical authorities concerned to focus their attention to see that Generic Medicines are made available throughout the country at affordable costs to the common man.

I am really perturbed by the recent escalation in the prices of Allopathic medicines. This is observed especially in the life-saving drugs that are imported; the medical lobby is looting the public. The medical drug authorities concerned should keep a strict vigil on them and should be penalized heavily. We are proud to know that our scientists are successful in sending economical missions like “Chandrayan” and “Mangalyan.” It is much more significant to achieve self-sufficiency in matters of nutritious food, clothes, shelter and medical drugs for our people. We have brilliant and dedicated scientists, doctors and pharmacists; the government should provide funds liberally and encourage them to invent and manufacture the required medicines at affordable prices to the common man. It is not advisable to import medicines from abroad and get exploited in the bargain. Try to avoid middlemen. I am of the opinion that it is the duty of the government to maintain not only the quality and quantity of a product but also to control the price of medicines and all other goods sold in market. In any event, the MRP (Maximum Retail Price) shall not exceed double the cost price of a product and would ensure that businessmen shall not loot the public.

Excerpts from

MEMOIRS

An autobiography

by

Joseph J. Thayamkeril

Lawyer, Kochi, Kerala, India.

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