Pharmacy

Market overview

Today, India is considered the "pharmacy of the world' as it now supplies one third of all the pharmaceutical products sold worldwide. Indian drug manufacturers attribute this success to continuous R&D on products and standardized process infrastructure. India has the largest number of FDA-approved manufacturing plants outside the US. Combined with a low cost of production, innovative scientific manpower and increased outsourcing of manufacturing processes to India, this makes Indian pharmaceuticals a powerful industry group.

The sector is currently experiencing an annual growth rate of around 16%. This phase of rapid expansion is due to the anticipated loss over the next few years of patent protection on major blockbuster drugs worth US$120 billion, with Indian generic drug manufacturers planning to capture more of this market.

 There are approximately 250 large units and about 8000 small-scale units that form the core of the pharmaceutical industry in India. This includes five Central Public Sector Units. It is now the third largest in the world in terms of volume and stands 14th in terms of value. According to data published by the Indian Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, total industry turnover between September 2008 and September 2009 was US$ 21.04 billion, of which the export market was worth US$ 8.25 billion. In an aggressive growth scenario, the Indian pharmaceuticals market has the potential to reach up to US$70 billion by 2020.

The country is committed to a free market economy and globalization and, for the first time in many years, the international pharmaceutical industry is finding great opportunities in India. It was once an extremely fragmented market with severe price competition and government price control. Now, the process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India.

Risks and issues

Over the past decade, pharmaceutical companies have entered a difficult period where shareholders, the market and regulators have created significant pressures for change within the industry. The Indian pharmaceutical industry has had to contend with several challenges, including the effects of new product patents, drug price control, infrastructure development, regulatory reforms, quality management and conformance to global standards.

 The pharmaceutical business is a global one and, if manufacturers' markets include the US and Europe, they must abide by the regulatory requirements set by the US Food & Drug Administration (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.

The migration process

Where glass containers were impervious to chemicals leaching through, the same does not apply to the new generation of drug containers and delivery systems that are made of plastics such as LDPE, HDPE and PP. Plastic containers are very convenient, especially for small units and where squeezing is required. They also offer increased efficiencies and reduced breakages and costs, BUT it is possible that components from label inks, laquers, top coats, adhesives, paper or film facestocks, or even the container itself, will leach through and contaminate or react with the medicine inside. The highest potential for migration has been observed with solvent-based inks, UV inks, top coats and laquers.

Threat to India's sales of pharmaceutical

products

The purpose of packaging is to keep medicines and personal care items fresh, and to protect them from direct contamination. It is important, therefore, for pharmaceutical manufacturers in India to be aware of the potential risks in changing from glass to plastic containers. Companies need to consider the threat to consumer safety represented by chemicals migrating from the packaging of all pharmaceutical products. Drugs might no longer have the expected effect, or there could be health- related reactions to the presence of unwanted chemicals. Such problems could cause loss of consumer confidence in the particular brand, resulting in reduced market share. By ensuring that all pharmaceutical packaging meets industry regulations, manufacturers can be confident in the safety of their products.

Although many Indian pharmaceutical companies are not aware of the stringent regulations and requirements regarding the migration of chemicals from packaging, others are realizing the importance of this issue and are meeting the challenge. Enhanced consumer protection is the main aim of these guidelines, so those in the Indian industry who are leading the change will be in a strong position to benefit from increased market share.

Avery Dennison has the right solutions

Faced with the potential loss of lucrative local and export pharmaceutical markets, it is vital that packaging designers and manufacturers in India ensure that any new pharmaceutical packaging they develop complies with the relevant standards and regulations.

It is just as important to choose a label manufacturer that has the experience and expertise to provide compliant labels. Avery Dennison has dedicated R&D facilities in the U.S., Europe and Asia, where skilled and experienced scientists and technicians work together with customers to develop sophisticated, cutting-edge labeling solutions. As a result, Avery Dennison is able to offer a guaranteed product portfolio of dedicated pharmaceutical label materials and adhesives that meet the regulatory and compliance requirements of the highest industry standards.

A Sophisticated range

They produce a sophisticated range of lightweight variable information products, as well as removable adhesives and flexible facestocks that are suitable for thermal transfers, direct thermal and laser printing. The portfolio features both film and paper facestocks, which deliver excellent print quality. Understanding of the demands of pharmaceutical packaging, these products deliver consistent low migration properties and excellent mandrel performance, even with small, thin-walled LDPE containers.

Extraction studies, comparing a range of adhesives available on the market, have shown that Avery Dennison S692NP™, a clear permanent adhesive, has the lowest risk of migration. One international pharmaceutical company tested it during qualification for use on containers of animal eyedrops. The extraction test delivered such excellent results that they decided not to continue testing other adhesives.

Additional support and consultancy services

Avery Dennison offers additional support to customers, providing a consultancy service and helping to produce any documentation that is needed to meet regulations. They have developed their own reliable testing methods and have data sheets and migration analyses available for standard products.

The technical representatives at Avery Dennison are also able to work with customers to develop customized solutions for particular applications, such as syringes, saline bags and blood bags that have critical packaging requirements. Apart from low migration characteristics, customers can also choose track and traceability features, plus anti- counterfeiting and anti-tampering devices. With an eye on the future, the change management policy at Avery Dennison requires that any necessary updates in packaging are planned at least a year in advance. This gives packaging manufacturers and brand owners ample lead time to maintain operational stability.

Opportunities for packaging manufacturers

The burgeoning pharmaceutical market presents packaging manufacturers in India with huge opportunities for business growth, provided that they meet the stringent regulatory requirements of world markets. With its global experience and expertise, Avery Dennison can be trusted to help manufacturers develop innovative pharmaceutical packaging solutions and to obtain regulatory conformance and quality compliance certification for their products.