Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA) is concerned about the product recalls to be made within 45 days which is June 30, 2013 following the enforcement of the  Drug Price Control Order (DPCO), 2013 which was notified on May 15, 2013. The Association has stated that the recalls will lead to rise in packaging and transportation costs. In this regard it is calling for meeting with its members and other pharma associations in southern India to discuss on how to take the issue forward.

There is also extensive delay on the price list. Now if the 348 drugs are recalled, in the absence of a price list, it would only result in affecting sales, said SG Biligiri, president, KDPMA and technical director, Juggat Pharma.

The government should not put the industry in such a problematic situation. The pharma industry has been a key growth driver for the country with a turnover of Rs. 1,10,000 crore and exports valued at Rs. 60 lakh.

“When the sector’s sales dip, it will only affect the healthcare of the people as the required medicines will not be made available,” he added.

Biligiri said that the pharma industry is apprehensive on the deadline of June 30, 2013 to withdraw all stocks from distribution. The move is causing concern as it is next to impossible to recall and go in for relabelling in such a short span of time. The cost of repackaging is 75 paise to rupee 1 per strip and added to this is the fuel price hike which hikes of cost of logistics.

Small and medium pharma players are also seeing a detrimental impact. Further, the sector’s growth prospects will also be marred with the economic slowdown. Measures are being adopted on account of lingering debt crisis, slower global growth and high cost of raw materials. All these negative factors have seriously impacted the company balance sheets, said the KDPMA president.

These are hindrances for the development of the pharma industry which is adhering the tedious procedures for drug clearances and registration. Many companies in the small and medium sector have been affected with poor export performance. Added to this is the new regulations imposed by European Union (EU) to implement its 'Directive on Falsified Medicines' adding delay thereby the chances of losing export orders are high. There is also a further strict surveillance by US FDA too on document submission, he said.

The government is just not able to comprehend the hardships when it has put forth the deadline for product recall and when it delays the price list yet still insists that the industry should withdraw the drugs within 45 days. Going by the number of pharmacy outlets in the country and the lack of personnel to monitor the recall of drugs, is causing more confusion and chaos, said Biligiri.