Expressing strong discontent over the provisions in para 13 and 24 of the Drugs (Price Control) Order (DPCO) 2013, industry wants the government to take immediate steps to reconsider and relax the norms mentioned in the same. Industry feels that the government should not make the revised ceiling prices, applicable on unsold stocks lying in the market prior to the notification and it should be enforced only for batches manufactured after the date of notification.
As per para 13 and 24 of the DPCO 2013, the new ceiling prices will be applicable to all stocks remaining unsold after forty five days of the date of notification. Experts from the industry pointed out that the implementation of the same within the stipulated time is an impractical proposition, as it requires not only recalling unsold stocks from countrywide retailers, stockists, distributors and C&F agents along with clubbing them with stocks lying with the manufacturers, but also requires them to be affix new ceiling prices.
In this regard, Confederation of Indian Pharmaceutical Industry (CIPI) recently made a representation to the government reiterating the extreme difficulty to comply with the 45 days time frame. CIPI said that it will be a herculean task for the industry to recall the formulations from the market from the huge network of retailers for re-labeling due to logistic and well as other technical reasons.
P K Gupta, chairman of CIPI pointed out that since the printing of price, batch number, manufacturing date and MRP on the strips and blisters is done on-line, opening it may hamper the quality of the drug. Whereas in the case of tubes, since the over printing of price is done in the form of crimping, it is technically impossible to change it.
“Apart from the logistics issues there are lot of technical glitches as well in complying with these conditions. If the stock is re-called the quality of the drugs may be adversely affected and the products with short expiry date may lose its validity resulting in unnecessary losses coupled with regulatory hurdles and problems with the excise and other tax authorities. In the view of these problems, the government should take requisite steps to ensure that the new ceiling price should not be made applicable to unsold stocks lying the market prior to the notification.”
According to Arun Naik, immediate past president, Goa Pharmaceutical Manufacturers Association (GPMA) to and from transportation of these stocks is likely to affect the stability with consequent reduction in shelf life particularly for injectables and antibiotic preparations. He further stressed that keeping in mind the interest of the industry the authorities should make the new ceiling prices effective from the batches manufactured on or after the date of notification as the case may be.
He suggested that with regard to unsold stocks lying with companies and their C&F agents, distributors,wholesalers and retailers, a statement duly certified by chartered accountants should be insisted to ensure veracity of companies' claims.