Pharmaceutical Industry: Total Quality Control Management

Article excerpt

The Drug Act of 1976 enacted the requirements of Good Manufacturing Practice as mandatory to be followed by Pharma Manufacturer. Perhaps, Pakistan was the first country in Asia where G.M.P. was made a Law in 1976 and implemented rigidly. The credit goes to the foresight of Masterminds in Drug Control Administration in Ministry of Health, Government of Pakistan, realizing the contribution and importance of G.M.P. in building the standard quality during manufacturing of Pharmaceuticals in Pakistan.

G.M.P. Laws in Pakistan included requirements regulating the specific criteria for building, equipment, personnel, marketing documentation to be followed for Manufacturing, Quality Control, Record for Production, Quality Assurance Procedures, Packaging, Labelling, Distributing Records, Stability Testing Record, Customer complaints etc.

There is no doubt that GMP enactment has resulted to scientific improvements and development in the delivery of standard Life Saving Drugs of highest quality in Pakistan. Both Drug Control Administration and Pakistan Pharmaceutical industry, deserve the compliments of its whole hearted implementation in Pakistan.

In order to have a clear prospective of the GMP enactment contribution in development of Pharmaceutical Industry in Pakistan, one should view the status of Pharma Industry in Pakistan at the time of its creation in 1947. At the time of independence, in Pakistan, there was no Pharmaceutical unit worth mentioning manufacturing pharma products in this part of the world. Most of the established Pharmaceutical manufacturing units remained in parts of India as in Calcutta, Bombay, Delhi etc. Almost all pharmaceutical requirements were met by imports from India and other foreign countries.

However, in a span of a few years a good number of National and Multinational Pharmaceutical units were established. Today, Pharmaceutical Industry of Pakistan has more than 300 units including 29 Multinationals, catering 80 per cent of Pharma requirements of the country, 20 per cent requirements are supplemented by imports.

Now our Pharma Industry has grown to the extent of having a market of Rs.48 billion approx. in the year 199697. Our industry is fully catering the requirement of standard formulated drugs, but still depends largely on imported raw materials from various multinational sources. At present a few Pharma raw materials as Aspirin, Paracetamol, Ibuprofen, Ampicillin, Amoxacillin, Trimethoprim, Ephedrine and few other materials are being manufactured in Pakistan but there still is a big gap in requirements and supply of materials being manufactured in our country. A good number of active raw materials are still required to be manufactured in Pakistan.

Realizing the economical importance of Basic Manufacturing for our country our Government very sensibly have offered good incentives. In order to attract further investment in raw material manufacturing, Government of Pakistan has recently offered very attractive terms and concessions as Protective duties, duty free import of plant and equipment, import of duty free intermediates, Tax holiday for raw material manufactured in Pakistan.

Our formulated manufactured drugs after achieving self-sufficiency of country requirements, are also being exported to other developing countries of Africa, Middle East, Central Asia, Bangladesh, Nepal, Sri Lanka, Afghanistan, Iran etc. Our exported products international, are competing with multinational products in foreign countries in respect of their quality, efficacy, presentation and are being preferred in competition to Indian products.

Our Pharmaceutical products are strictly manufactured under rigid Good Manufacturing Practices and controls and Pharma plants are inspected by Federal, Provincial Drug Inspectors 2-3 times in a year, conforming GMP being followed by the manufacturer in manufacturing and Quality Control as laid down by World Health Organization. …