GMP is a concept that goes beyond manufacturing. It involves commitment to total quality across the organization. The concept of GMPs has to be imbibed in the very culture of the organization. One of the key parameters of GMP is to maintain high degree of sanitation and hygienic conditions in the manufacturing facilities and by the personnel operating the machines. In order to create zero-defect goods and services, the management has to build an organization-wide culture of quality. This commitment to quality has to be a top down approach.
Production of drugs and pharmaceuticals is a multi disciplinary subject, wherein the personnel involved should have knowledge about the various aspects of drug manufacturing and testing, which include chemistry, life sciences, engineering, computer applications etc. Being a highly technology-oriented sector, the pharmaceutical industry is very dynamic and the trends and practices keep on evolving. To keep up with this constant flux the industry has to improve its knowledge base. The technology and personnel need to be updated and continuously trained depending upon the requirements of the organization.
Apart from creating state-of-art facilities for manufacturing of drugs it is important to give attention to all elements of the supply chain to ensure a zero-defect product. The raw materials have to be from a supplier complying with the GMP requirements, whether it is an active pharmaceutical ingredient, excipients, packing material etc. Similarly adequate attention has to be given to the Work-In-Progress (WIP) and subsequently the storage, transportation and distribution of the finished goods. It is very imperative that the organization selects appropriate distributors with the requisite infrastructure for the storage of the finished formulations. For e.g. A sterile injectibles or a biotech product requires a cold chain for transportation and storage without which the active ingredient might become unstable.
The Indian pharmaceutical sector is currently the largest amongst the developing nations. Given its current momentum of growth the Indian pharmaceuticals market is expected to expand to US$ 25 billion by 2010. It is one of the flagship sectors of the Indian economy, as Indian pharmaceutical companies continue to move to the center stage of the global pharmaceutical market. The market is predominantly a branded generic market with more 20,000 domestic manufacturers of end-use pharmaceuticals, making the industry highly fragmented.
In the organized sector of the Indian pharmaceutical industry there are about 250-300 companies, controlling about 70% of the total output in value terms, with top 10 players accounting for one third of the total market.
India has entered a new era with the TRIPS-compliant patent regime. Today, the country presents major opportunities for multinational pharmaceutical companies in clinical trials, contract research and manufacturing. The licensing opportunities for big pharmaceutical companies as well as the collaborative business model including services give access to low-cost intelligent base, indigenous technology and most importantly the large domestic market. Many multinationals are now looking at India for product launches, excellent chemical and process engineering skills, partnerships and acquisitions to capture a share of the Indian pharmaceutical pie.
All of these changes are ultimately good for the Indian pharmaceutical industry, which suffered in the past from inadequate regulation and large quantities of spurious drugs. They have mandated that the industry reach a level necessary for global competitiveness.
The Drug & Cosmetics Act, 1940 which governs the import, manufacture, distribution and sale of drugs in India has an established authority under the Drug Controller General of India (DCGI). The DCGI is responsible for the approval and registration of drugs, issuing of manufacturing & marketing licenses and overseeing the conduct of clinical trials.
The government has ensured that Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) compliance become a practice in India. Different compliance monitoring authorities are being put into place for the same.
To compete in the global arena Indian pharmaceutical companies have upgraded their manufacturing facilities over the years to international standards which are not only GMP compliant but approved from international bodies like US FDA, UK MCA, MHRA and the like. Today, India has the largest number of US FDA approved facilities outside US i.e. around 80 and the number is increasing rapidly. On the basis of these state-of-the-art facilities, which are also low cost as Indian companies are traditionally vertically integrated, the Indian pharmaceutical companies are attractive destinations for MNCs for contract manufacturing and/or global sourcing for supply of bulk drugs/intermediates.
Inspite of the increasing number of FDA complaint facilities and many others who are gearing up for approvals, there are a number of small pharmaceutical companies who are reluctant to comply with GMP guidelines. Today, when GMP has become a minimum expectation form the industry, the smaller companies need to realize the importance of GMP and its benefits to their business operations.
Today, when the Indian pharmaceutical industry is looking at the world markets for growth through international business, compliance to quality standards is a must. GMP certification will enable companies to get US FDA approval quicker as GMP compliance will assure that drugs are manufactured keeping in mind drug quality.
Thus, the Indian pharmaceutical industry has to upgrade itself in all aspects of GMP to have continued presence in the global market and to meet the increasing demands of the dynamic and technology driven industry.
- (Shivani Shukla, is Industry Analyst, Healthcare Practice, Frost & Sullivan. The author can be reached through Samantha: sunnikrishnan@frost.com)