With more advancements coming in the pharma packaging, the regulators at the national and international levels are stressing on pharma companies to increasingly comply with child resistance packaging norms, while at the same time be user friendly.
According to Chakravarthi AVPS, chief executive officer, and MD of Ecobliss India, of late the regulators both at the domestic and international levels are increasingly demanding the pharma companies to comply with strict regulations with regard to child resistance and user friendly packaging. “It is mandatory for the pharma companies to follow scientific packaging methods. In addition to branding the packaging models should also addresses the product needs, patient convenience and product security. Of late regulators are stressing more on child resistance and user friendly packaging models,” said the MD.
Today the Indian pharma industry is contending with several challenges including the effects of new product patents, drug price control, infrastructure development, regulatory reforms, quality management and conformance to global standards. With new regulations coming in, the Industry must continuously incorporate them to be in the competition fray internationally. The pharma manufacturers must abide by the regulatory requirements set by the US FDA, and the European Medicines Agency (EMEA), as well as national boards such as the Drug Controller General of India (DCGI). In particular, compliance with the regulations dealing with the migration of contaminants from packaging to contents should be a major focus for India, opined Chakravarthi.
In the recent times, the Indian pharma companies have been facing a lot of resistance for their products for lack of proper packaging and for not complying with international packaging guidelines. Because of which, the US FDA and EU regulators have blocked imports for certain non compliance packages from India and had even blacklisted certain pharma companies banning imports from them. To address this many Indian companies have to re look into their product packaging lines and incorporate the missing aspects to full fill the regulatory compliance. “While it (packaging) has to protect the product integrity it also must help the patient safety. Child resistant and tamper evident packs will be in major demand as they protect children against incidental and accidental poisoning,” said the chief executive officer.
Stressing on new developments in pharma packaging, Chakravarthi viewed that single-dose formats are capturing sizeable market and this trend will increase. The challenge is to keep the pack as compact, yet inform users as clearly as possible about whatever information they need. With the surge of temperature sensitive drugs, packaging companies also need to address cool chain packaging solutions in the secondary and tertiary packaging models.
In the coming days combination products also called as combo drug packs will see more acceptance and it's a challenge for packaging developer to offer a solution for packing heterogeneous products yet following compliance requirements. With self administered therapies to increase in the future, the pharma companies should provide injectable drugs and prefilled syringes with accurate dosage. So the packaging must ensure dosing accuracy, tamper evident, follow compliance and at the same time it also must help prevent drug spray-back and more importantly help prevent accidental injuries due to needle sticks. So keeping all these developments, packaging firms needs to upgrade their packaging lines be prepared to meet the future demands, viewed the chief executive officer.