Emerging technology and trends in Indian pharma industry
An emerging trend in the pharmaceutical industry is manufacturing and sterility testing under isolators
The Indian pharmaceutical industry is one of the world’s largest industry, ranking fourth in terms of volume and 13th in terms of value in the global pharmaceutical market. The industry registered sales turnover of US $5.5 billion in 2004, growing with an annual growth rate of eight per cent.
It is the adoption of emerging technologies by the Indian pharmaceutical industry that has led to better and efficient processes in terms of cost benefits, purity of the product, yields and enhanced safety of products rolling out of the industry, at large. This article is an overview of some of these emerging technologies which has helped us in being a cut above the rest.
The pharmaceutical industry has been on a growth curve that has seen a steady rise since independence. The industry has catapulted from the multinational monopoly stages (during 1960s) to the present stage of having Indian multinational set-up and one of the change agents that has been the strength of R&D revolution.
Over the last decade, the pharmaceutical industry has achieved and developed a lot of expertise on formulation and development for a number of sustained release formulations. Such formulations have gained the confidence of medical fraternity and seen good commercial success in the Indian pharma market due to the ease of use and helping to ensure high patient compliance.
The pharma industry is also foraying into areas of Novel Drug Delivery Systems (NDDS) which enable that the prescribed dosage reach directly to the specific affected location/organs, ie, targeted delivery approach over a predetermined period of time. Since many of these NDDS have to be sterile (eg. implants) the availability of advanced tools and technologies in aseptic processing and the additional initiatives of validation concepts being in place, R&D groups feel enabled to work on these sterile NDDS with confidence.
With the current scenario of disappearance of geographical barriers in the global pharma market, the Indian pharma sector is galloping on its own strengths. Expertise in synthetic chemistry and pharmaceutical manufacturing have allowed the Indian pharmaceutical sector to position itself as the provider of quality products at highly competitive price. Our industry has exploited this advantage to make forays in the global generic market. As a result of this, many leading Indian pharmaceutical companies have become some of the most efficient manufacturing units in the world.
With patent expiry of many blockbuster molecules now, the Indian pharmaceutical industry stands at a threshold of a golden era to mark its presence in the global generic market. With the availability of expertise and validation services of international standards (now in India itself), many Indian pharmaceutical companies have already got themselves into an enviable position by procuring regulatory approvals, enabling them to market their products in developed countries.
Another emerging trend in pharmaceutical industry is manufacturing and sterility testing under isolators. At the Pharmaceutical Science Advisory Committee meeting held on October 22, 2002, committee guests agreed that FDA should encourage the use of isolator technology via an open regulatory environment. Isolator technology allows for fewer opportunities for microbial contamination during critical operations, eg, vial filling, sterility testing etc. It also offers increased product and operator safety by complete containment of the drug which is very critical for products like cytotoxics, biologicals etc.
Some leading Indian pharma companies have adopted the use of this technique to have sterility assurance for the product as well as ensure containment. It is achieved keeping in mind safety for operating personnel. Specialised process monitoring tools are available for isolators with respect to microbial air-monitoring and sterility testing, making processes and environments inside of an isolator better and easier to maintain and monitor. Rapid microbiological techniques that help in easing out the burden of maintaining products in process and aid in assessing the quality of the products, under the PAT regime is another of the proofs to demonstrate the emerging aspects of science working for the industry!
Another of the famously acceptable techniques, which is changing the face of aseptic processing is disposable technology. The recognition of disposable manufacturing technology is increasing and seen as a versatile alternative to traditional stainless steel based facilities in the Biopharmaceutical industry. Greater flexibility for operations, plug and play devices have caught the attention of organisations aiming to get to the market place quicker.
Gathering data during validation studies for the disposables during research can be used to accelerate its use and implementation at manufacture by using an equivalent disposable system. Some of the specific tools that are available to Indian pharmaceutical manufacturer are capsule filters, disposable sterile connectors, filling machines with disposable filling head, microbial monitoring devices etc. These are just few examples of various technologies and tools which are gaining popularity mainly due to cost economics, ease of use, not being labour intensive and being accepted due to validation possibilities to prove consistency, safety, purity and quality. Looking ahead into the futuristic trends that may revolutionise the industrial practices, one may state that any technology that makes the process of bringing a blockbuster to the market at lightning speed will be a clear winner!
—Courtesy: Millipore India