Safeguarding interests of Indian pharma SSI

Performance improvement methodologies and management approaches shall offer SSIs a greater chance to succeed and be recognised as a benchmark in the industry, says J Ramniwas

The countdown for the implementation of Schedule M for the Good Manufacturing Practices (GMP) compliance has begun and all pharmaceutical industries are now busy with the structural changes to comply with the requirements. With the sunrise of January 1, 2005, the Schedule M will be effective and any non-compliance will lead to the closure of several pharmaceutical industries. This is transformational phase for all Indian pharmaceutical industries particularly for the SSIs.

A bitter truth that will shape the course of future development for Indian pharmaceutical manufacturers. All of us have to accept this ground reality, which will safeguard the interests of all pharmaceutical organisations to meet the future challenges. Though initially it would be uncomfortable, GMP will bring dividend to SSIs’ business in the long run. Because the revised Schedule M addresses almost all the requirements of existing quality systems the world over.

The decision taken by the Ministry of Health and Family Welfare, Government of India will help in opening the new gateways of success for all pharmaceutical organisations in the face of science-based risk management decisions to provide the safe and quality products to the patients who show their confidence in your products. Full implementation of Schedule M will boost up a company’s confidence and organisations can easily win the war of quality.

Pharmaceutical is a highly critical sector so far as quality and competitiveness are concerned. These two parameters play a significant role for this sector and can make or mar their fortune. Being a pharmaceutical organisation, they cannot take shortcuts with the five corner stones of production process, functionality, consistency, standard practices and stringent quality control. Because these assume paramount importance for healthcare products and any compromise in this field can be a gamble with human life.

So pharmaceutical organisations always target for excellence and aim at perfection. That is what revised Schedule M advocating for. This proactive, long-term planning minimises the need for crisis management. Knowing the real problems and providing corrective action before

facing a survey prevents unexpected deficiencies. Comparatively, performance-improvement methodologies and management approaches offer the organisation a greater chance to succeed and be recognised as a benchmark in the industry.

New regulatory requirements in the pharmaceutical industry under harmonisation globally bring about borderless trade opportunities. To achieve and maintain the standards required to capture the overseas markets and even to statutorily observe the GMPs as contained in the revised Schedule M of the Drugs and Cosmetics Rules, the SSI units in pharmaceutical industry will be required to make huge investments in plant machinery and equipment.

An inevitable outcome of the implementation of GMP by January 2005 will be the beginning of a consolidation process in the Indian pharmaceutical industry. Now the success of adoption of GMP in the industry will totally depend on how various state drug authorities are going to implement the same. If all the major states producing pharmaceuticals are implementing the norms by early next year, one can say the goal is nearly achieved.

The impact of Schedule M implementation will prove very fruitful to all Indian pharmaceutical industries as the United States Food and Drug Administration (FDA) is moving boldly and aggressively to update and revise systems for ensuring manufacturer compliance with good manufacturing practices (GMPs). The year 2005 marks the beginning of a new phase in the development of Indian pharmaceutical industry.

The compliance of Good Manufacturing Practices (GMP) becomes a statutory obligation from the New Year for all drug units in India under the revised Schedule M of the Drugs and Cosmetics Act. The very objective of this regulation is to enhance the minimum manufacturing standards for bulk drugs and formulations across the country. It is not possible to maintain a uniform quality of pharmaceutical products in the country without ensuring standards for clean rooms, proper drainage system, standard packaging materials, storage rooms, etc prescribed under GMP norms.

A change towards GMP at manufacturing facilities is also felt necessary as India’s image is changing to a quality supplier of pharmaceutical products to the world markets. Several organised sector drug units have already gone far beyond GMP and have US FDA and UK MHRA approved facilities.

Come 2005, it’s not going to be the same ever again. Even the most indomitable in the global pharmaceutical business will need to do a rethink on the strategies that have served them so well in the era gone by. As the walls of complacency come crumbling down, it is a time for introspection whereby companies are trying to find means of creating and building advantages rather than just eliminating disadvantages. It is no longer a matter of being better at what you do; but it’s all about being different at what you do.

(To be concluded)

The writer is senior manager, QA, Tonira Pharma Ltd, Vadodara