Pharmaceutical quality and the world

Pharmaceutical Quality and the world
Internationally India is in 4th position with respect to the volume of drug products manufactured and is a leading competitor in the generic drug market. However within India there appear to be two levels in the philosophy of quality maintenance; with some companies meeting all international specifications and some failing to meet even basic requirements. Internationally quality assurance is going through new trends. US FDA and international conference on harmonization (ICH) are driving this struggle for higher and higher levels of pharmaceutical quality and its optimization by issuing guidelines such as pharmaceutical development Q8 (R1) and pharmaceutical quality system Q10.
When the word “Pharmaceutical quality” is used with respect to a medicine it reflects on its drug content, its elegance, its dosage form properties and its stability characteristics. The designation ‘Quality’ applied to a drug product requires that the product:
 Contains the quality of each active ingredient claimed on its label with in the applicable limits of its specifications.
 Contains the same quantity of active ingredient from one dosage unit to the next.
 Be free from extraneous substances.
 Maintains its potency, therapeutic availability and appearance until use and
 Upon administration releases the active ingredient for full biological availability.
Prior to 1960s there were not many controls over introduction of new drugs and also over the assurance of the quality by the manufacturer over his established drug products. Some stray tragic incidents in some countries like USA and India triggered the introduction of exacting drug laws to ensure the quality, safety and efficacy of the drug. Around 1970s the pharmaceutical industry started getting global but the registration of medicines remained a national responsibility. Although the laws of all the countries were based on the same fundamental obligations to evaluate the quality, safety and efficacy the detailed technical requirements differed from country to country. So the companies had to duplicate many time consuming and expensive test procedures, in order to market new products, internationally. All this resulted in unnecessary expenses and long delays in introducing new drugs.
So a necessity to harmonise or make uniform, the testing procedures and regulatory requirements of different countries was felt and the result is the birth of ICH in April 1990.

The birth of ICH took place at a meeting in April 1990, hosted by the EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the USA met primarily to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH. The ICH steering committee which was established at that meeting has since met at least twice a year, with the location rotating between the three regions.
The topics first chosen for harmonization were safety, quality and efficacy and Expert Working Groups were set up to discuss scientific and technical aspects of each harmonization topic.
In the last two decades ICH has done wonderful work and developed many guidelines and many levels of excellence for enthusiastic companies to meet. Such expert groups are a source of inspiration for any field of science. Yes, I would like to talk about ICH in the coming days.