Industry wants govt to enforce SCM standards for dry pharma products
Industry wants the government to take initiative to push for better implementation of regulations of the non cold-chain based supply chain management (SCM) of pharma products, to ensure safe delivery and availability of quality products to the patients. Many in the industry strongly contend that even the dry pharma based cargo should be transported only under strict temperature controlled environment to ensure sustainability of the pharma products from volatile conditions.
Today, temperature controlled transportation of products using cold chain facility is only ensured for the distribution of vaccines and some pharmaceutical or biological products through thermal and refrigerated packaging methods to protect the products from loosing their effectiveness. However, according to an industry expert who exclusively deals with the logistics and transportation for some of the top pharma companies in the country, it is essential that at least some level of regulation is maintained while even dry pharma products are being transported from one place to the other.
He pointed out that over the years there have been incidences wherein pharma companies have openly flouted the rules by not adopting the required regulatory standards needed for the transportation of these products. He added, “We have observed that there are many companies who do not follow the present regulations as implied and required by the law which is putting at risk the quality and efficacy of drugs that is being transported from one destination to the other. It must be realised that even though the dry products do not need to be maintained at the same level as some of the temperature sensitive products there certainly needs to be at least some kind of controlled regulation while transporting dry pharma products.”
Like in the case of temperature controlled products even for dry pharma products there are chances of their effectiveness being compromised due to widely varying environmental conditions involved during the transportation process.
Sources from the industry stressed that there should be at least some kind of mechanisation that needs to be adopted by the companies to determine the effects of temperature excursions on the products, with stronger use of track and trace system to accurately track and trace the position of the products across multiple time zones.
Industry insiders pointed out that these conditions are prevalent in the country because of lack of proper implementation of the present rules and regulation. He stated, “Pharma companies should understand that they need to adopt proper cold chain standards for all pharma based products to ensure the delivery of safe high quality drugs. For this to happen the Government should take the requite steps for stronger implementation of the standards so that all the companies are forced to follow them. This will not only help in the availability of high quality products to the patients but also will strengthen the reputation of the drugs that are manufactured within the country.”