Dr Reddy's beefs up quality image
world to receive a new verification mark for two of its products,
it was announced last week at the CPhI trade show in Milan.
The mark was given by the United States Pharmacopeial Convention (USP) under its newly-implemented Pharmaceutical Ingredient Verification Programme (PIVP), after it performed an independent quality assessment of two generic active pharmaceutical ingredients (APIs), ramipril and finasteride, made by Dr Reddy's at its Hyderabad plant. USP is a not-for-profit, non-governmental organisation, originally set up by a group of physicians, and is the official public standard setting body for all prescription and over the counter (OTC) products manufactured in the US. It has been also running validation programmes for OTC substances for some years and as of October last year extended its scope to cover prescription pharmaceutical substances. Dr Reddy's was the first to sign onto the new PIVP programme in April, putting four of its APIs under scrutiny, two of which have now passed and two of which are still undergoing the process, which usually takes six months, USP spokesperson Rich Wailes told delegates during a press conference. "At this point, three other companies are also undertaking the PIVP," he said, adding that they were from either India or China. "Most drug substances now come from these countries so we expect most of the programme participants to also come from there." The PIVP is a voluntary programme, and when questioned as to what added benefit it would bring to drug substance manufacturers, who already have to undergo rigorous scrutiny in order to sell their products for use in the regulated market, Wailes told Outsourcing-Pharma.com: "USP adds one more element of safety and comfort for manufacturers and their customers." "There are many thousands of drug substances and we provide an independent science-based review of the quality assurance and quality control processes being used in the manufacture of a substance that we give our mark to, therefore putting our reputation on the line that customers can be reassured that they are getting consistent ingredients." Wales then clarified the role of USP. "We are not a regulatory body - we differentiate ourselves by saying what does pass, as opposed to what doesn't pass, and then imposing fines." "We want to put a spotlight on what we know is good." The organisation said its certification, which is valid for three years, differs from that of the International Standards Organization (ISO). "ISO looks at the systems that are in place but does not look specifically at a drug substance," said Wailes. "In many cases the ISO certification doesn't include a good manufacturing practice (GMP) review of the facility." "USP's standards are enforceable by the US Food and Drug Administration (FDA), where as ISO's are not," he added.
