Pharmaceutical packaging comes of age in India, with more stringent quality measures being put in place
By MITALEE KURDEKAR
YEARS AGO, DURING AN OVERSEAS VISIT, I noticed that a commonplace antibiotic was packaged differently, and so much better, than it was in India. I soon discovered that this was the case with many medicines and drugs, and the reason was simple: cost. It was difficult for Indian pharmaceutical manufacturers to pass on the additional cost of good quality packaging to the end user, and therefore, the packaging ended up being of inferior or mediocre quality. But things are slowly changing.
“The talent and efforts of Indian entrepreneurs has created one of the world’s largest and fastest growing pharma industries by volume. It leads the world in generics. However, safe packaging and distribution is a weak area. The situation is being corrected, but we are rather late,” states Ajit Singh, chairman, ACG Worldwide.
Since it provides an important protective barrier against exposure to dust, bacteria, dirt and the like, in addition to acting as an effective obstruction to light, moisture and other volatiles to keep product stability intact, packaging becomes almost as important a factor
as the manufacturing process for a drug.
Good packaging also provides critical information to the patient, pharmacist and the doctor, and is a means of ensuring that a particular medicine is dispensed as prescribed. It also takes care of the fact that a medicine remains safe and efficacious up to the expiry date that the packaging material displays. Besides, packaging development efforts for the pharmaceuticals industry have also recently inclined towards creating value for the patients by providing dosage compliant packs to facilitate and ensure complete, prescribed drug intake.
“Packaging plays a major role in the distribution and safe consumption of drugs and medicines. The quality of raw materials used, especially for primary packaging, has a direct effect on the packaged drug, as the drug is in direct contact with this packaging. Therefore a lot of stability and validation data needs to be generated to ensure that the drug remains stable throughout its shelf life. A robust packaging also helps to eliminate/control spurious drugs,” says Kairus Dadachanji, managing director, Schott Kaisha Pvt. Ltd.
Echoing this sentiment, Troy Webb, site director, global manufacturing & supply, Nashik site, GlaxoSmithKline Pharmaceuticals Ltd, states, “Packaging is a key component of drug manufacture, storage and supply. It provides the necessary protection of the drug from the environment to ensure that the medicine is not compromised over time. For example, the product does not get impacted by the humidity or temperature if stored at the recommended storage conditions. It also protects the product from breakage, which is critical in the context of dose consistency.”
THE INDIAN PHARMACEUTICAL industry has evolved tremendously over the past few years, particularly in the context of quality consciousness and quality standards. This has reduced the gap in manufacturing standards, between global players and domestic producers. Commenting on this, Rajul Parikh, co-founder & director, Alfaa UV, states, “All pharmaceutical industry players in India, whether Indian or multinational, have a level playing field when it comes to regulation, policy and manufacturing norms. Besides regulatory and compliance related obligations, quality consciousness is now more of a culture within organisations, whether they be multinational or Indian.”
There are many trends in packaging today that are helping to further ensure product safety and efficacy. According to Dadachanji, the advanced technology trends being witnessed today revolve around the creation of checks and features in order to identify original from spurious (counterfeit). Also, more automation and tighter inspection parameters are being pursued, while Good Manufacturing Practices (GMP) and clean environments are being sought as well.
In order to give a thrust to quality exports in pharmaceuticals, the government of India has introduced legislation to have bar-code compliant processes to ensure tracking and tracing of individual packs. “On line bar-code recognition ensures that all components are correct to serialisation, which allows us to track a batch from factory to box to individual pack and support the elimination of counterfeit manufacture. The use of vision systems (on line camera inspections) to check everything from counts to printed material to quality attributes are also key emerging trends for effective and efficient packaging operations for the pharmaceutical industry,” points out Webb.
Apart from bar-coding, sophisticated holograms, aluminium seal caps on vials etc., some of the latest features in anti-counterfeit measures include laser marking for glass syringes and containers, and circular marking on hard gelatin capsules. These involve a high capital investment and therefore act as a deterrent to counterfeiters. Serialisation, where every pack has a unique identifier that can confirm if a product is unique to highly complex packaging artwork, is making counterfeit operations difficult to carry out, says Webb. He also adds that locally sourced vendors are becoming more sophisticated and local technology is coming closer to the more established big names in packaging technology.
“Effective anti-counterfeit solutions have been developed by innovative suppliers, but are still sparingly used by the industry. It appears not to be generally known that the Government welcomes the adoption of such measures and the additional costs, within reason, are acceptable,” says Singh.
He opines that the most cost effective and easiest to adopt method is possibly complex multicolour printed capsules. These come ready to use, and are only a fraction of the cost of the empty capsule container, which again is a fraction of the cost of the pharmaceutical product, making it a viable alternative. “A simple and effective alternate method of separating active ingredients in a single dosage form is by using smaller capsules, which are filled and inserted into mother capsules. As many as four separate actives can be incorporated into one unit dose and in separate compartments, including even liquids and powders together. The savings in overages itself pays for some of the extra cost, and the process is automatic. More aggressive promotion of these novel products and greater receptivity from the pharma industry is needed,” proposes Singh.