Health

KEY POINTS

·         In India, most of the patients spend their medical expenses out from their pockets.

·         These healthcare costs pushed 60 million Indians below the poverty line in 2011 census.

·         Therefore, even a modest drop in drug prices will free hundreds of households from the widespread phenomenon of a medical poverty trap.

Generic drugs

·         Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, route of administration and safety as the original drug.

·         In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

·         Generic medicines are affordable versions of the drug, introduced after a company loses patent over a medicine.

·         Generic drugs are cheaper because, the manufacturers have not had the expenses of developing and marketing a new drug.

Challenges before Generic medicines

• Bio-Equivalence Test are studies conducted to establish that the original patented drug and a generic version work the same way, to the same extent and for the same purpose. 
• In India, the coverage of bio-equivalence test is not universal, it is required only for some classes of generic medicines and enforcement is yet to be evaluated.
• This creates an opportunity for malpractices to secure marketing authorizations, approving drugs without conducting clinical trials, and accepting bribes from companies for fast approval of products.
• Poor regulatory regime makes it hard to recover generics from the dented perceptions about its quality.
• Usually, generic products don’t advertise and save costs that way.
• But, the good-quality manufacturers are not able to compete with shoddy manufacturers on cost, thereby driving the good-quality generic manufacturers to advertise and become branded generics, or exit the market.
• Certification practices by the government can mitigate that problem and allow good-quality generic medicine manufacturers to differentiate themselves on a variable other than price.
• The incentive to cut costs increases as massive government contracts are allocated to the lowest bidder.
• This probably explains why over 10% of the medicines in the government supply chain were found to be not of standard quality (NSQ)