It is an undisputed fact that excipients are as important, if not more than the actives in any formulation. Especially in the pharma industry, consistency and rigour of excipients have to be unquestionable. To reach this level of assurance, all parameters of production, QD, packaging, safety, transportation etc. have to be excellent.
The WHO in its essential Drugs & Medicine policy has laid down exhaustive guidelines for excipient manufacturers. Briefly, they are:
1. Equipment
1.1 Use of equipment
1.2 Cleaning programme & procedure
1.3 Sampling plan
1.4 Analytical methods
2. Materials
1.1 Starting materials
1.2 Rejected & recovered materials
1.3. Storage practices
3. Documentation
1.1 Specifications
1.2 Batch production records
4. Good practices in production & quality control
4.1 Change control & process validation
4.2 Good practices in production, prevention of cross contamination and in process blending.
4.3 Control of microbial contamination
4.4 Packaging operation and delivery
4.5 Quality records
4.6 Stability studies & revaluation dating
There have been several instances when in the non performance or less than adequate performance of the excipient have rendered many a batch, useless or unstable or caused even more serious problems at a later date.
Pharma companies and excipient companies generally work together. Different routes of administering drugs, issues viz, solubilization, absorption enhancement, improved processing, safety, toxicology studies etc. have to be understood by excipient manufacturers to develop appropriate products. A strong R & D infrastructure is needed by them to partner with Pharma companies.
In India, the excipient market is dominated by foreign MNCs. Nearly 75% of all excipients and almost 100% of sophisticated excipients are supplied by American, European or Japanese companies. Chinese and Korean companies have been trying but have had very limited success. Normally, a good excipient manufacture would need a certain economy of scale for which accessibility to a large market would be a pre-requisite. For this reason, domestic companies opted more for APIs or other large volume commodity chemicals and stayed away from excipient manufacture. Certain producers did try and make speciality products but most of them have still stayed either too small to affect the MNCs or many have even closed down.
The steady decline in import duties from around 150% to the current 25% has also played a big role in their increased usability. The formulation Pharma companies have benefited because of cheaper and easier availability of any and all excipients. It aided their export efforts in entering developed markets. Stringent FDA guidelines insist on usage of only familiar and approved raw materials. Some of the new international regulations include TSE/BSE, OVI, GMO and several other qualifications that most Indian excipient companies would find difficult to comply.
Most major excipient producers have a presence in India either direct or through Distributors. India is a favoured market for new product introduction. R & D personnel here are known to be very enterprising and innovative. Also, constraints of avoiding process patents, cost considerations, DPCO, focus on exports etc. all lead them to try out newer options and create niches in their respective segments. Compared to this, developed markets are relatively slower in changing source or process for existing products.
India, as a Pharma base is becoming a serious force to reckon with and most producers are aware of the tremendous potential and challenges that lie ahead for a market of more than a billion people. With the GATT era looming up, new challenges are cropping up and the entire industry is reinventing itself to become a part of this exciting global scenario. Competition between different companies will heat up, mergers and acquisitions are becoming common and the whole industry is getting more vibrant.
- (Source: Interphex 2004)