Every Indian pharma company making generics must have WHO Good Manufacturing Practice (GMP) certification. Factories are inspected regularly for cleanliness, equipment, processes, and documentation.
The generic must prove it delivers the same amount of active ingredient into the bloodstream as the original, at the same rate. This is tested in human clinical studies.
Every batch of medicine is tested for purity, potency (correct dose), dissolution (how fast it dissolves), and absence of contaminants before it can be sold.
CDSCO regularly collects random medicine samples from the market and tests them in government labs. Substandard medicines are recalled and manufacturers penalized.
Jan Aushadhi specifically mandates third-party testing by NABL-accredited labs for every batch of medicine sold at their stores โ an extra layer of quality assurance.
Only the inactive ingredients (excipients) may differ โ these are fillers, binders, and colouring agents used to make tablets. These generally don't affect how the medicine works. In very rare cases (~1 in 10,000 patients), someone might have a reaction to a specific excipient, but this is unrelated to the active ingredient quality.
Tablet shape, colour, and packaging will look different โ but these are cosmetic differences, not quality differences.
AIIMS New Delhi, PGI Chandigarh, government medical colleges, and all state government hospitals exclusively use generic medicines. If generics were lower quality, the government wouldn't use them for crores of patients annually.
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