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BR Research

Ensuring quality at pharmas

Published January 25, 2012 Updated January 25, 2012 12:00am

pharmaThe inevitable has happened. In all reality, it was only a matter of time before the substandard drugs took human lives-and that is exactly what happened recently in Lahore. The government as usual has taken otice of the offense and arrests have been made in this regard, but precious lives have been lost and there is little compensation that can account for their loss. There should be little surprise that the incident actually took place-the surprise is in the part that why and how did it not happen before on such a massive scale. It could only have been a miracle, because the state of affairs in the pharmaceutical industry is shocking, to say the least. Pharmaceutical industry is strictly regulated where almost 100 percent drug prices are completely regulated. This is where the leading pharma players have been raising voices, which have mostly fallen to deaf ears that the focus should be on regulating the quality aspect more than prices. "The government should put greater emphasis on quality check....there are only 50 companies that are operating in good manufacturing environment and putting in the right quality," said Salman Burney, CEO, GlaxoSmithKline, in an interview with BR Research, back in 2009. This should be an eye-opener for the government, more for the provincial governments now, as healthcare is now a provincial subject after the 18th Constitutional Amendment. The presence of over 400 pharmaceutical companies has long been criticised by industry watchers, who believe that this creates room for substandard practices and spurious drugs as the ministrys capability to monitor and ensure quality standards is limited. Drug manufacturing is a sensitive business and it should not be dealt with a carefree attitude of treating the industry as a cottage industry. This is how a large number of smaller pharmaceutical companies operate, blatantly violating even the minimum safety and standard requirements, let alone adhering to the global ones. The industry has long been pleading for a separate regulatory authority for pharmaceutical companies-along the lines of Ogra, SECP, etc. The Drug Regulatory Authority should be mandated to ensure that quality standards are not compromised and a benchmark needs to be set irrespective of the size and origin of the firm. The recent tragedy should also be an eye-opener for the respective governments as the process of drug procurement at the government hospitals surely merits a revisit. The substandard manufactures need to be treated as criminals and there should be no mercy shown-nothing less than the closure of substandard setup should be tolerated.

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