‘Companies should be committed to quality for their own survival’

R S Iyer has been spearheading quality assurance in pharma companies during his three decade long association with Glaxo Laboratories India Ltd in Mumbai. Iyer, a post graduate in Analysis of Foods, Drugs and Water from the Royal Society of Chemistry (RSC) London began his career as an analyst in the QC laboratory at Glaxo, rose to become the chief analyst in 1968 responsible for all aspects of QC of the company’s pharma products, chief QC manager, GM of Thane plant and served a brief stint as GM commercial before taking over as Corporate QA director and VP QA before retiring in 1985. A consultant to the pharmaceutical industry on GMP, QA, technical audits and compliance with regulatory requirements worldwide today, Iyer is the longest serving member of the Indian Pharmacopoeia Committee. In an interview with Vijaya K, Iyer lays stress on the committment for management for quality. Excerpts:

As a member, could you comment on the Indian Pharmacopoeia Committee?

I have done my best for what the Indian Pharmacopoeia Committee is today. With better representation from the industry now, there has been some improvement in the quality. The concept of a working group was also suggested in the group. We had a working group carrying out all the important functions of the Committee. With our efforts, the printing is no longer an exclusive right of the government printing press but done privately to improve the quality of IP. Now we are planning to set up an IP Commission to ensure safer and effective drugs which is expected to have its own funding arrangements and its own secretariat. The concept, awaiting cabinet clearance, will function as an autonomous body. The commission, if it gets cabinet nod, will be ready by next month. With a huge corpus given by the World Bank, it will bring about IP regularly.

The recommendation given by experts says that the commission should be a body of professional people and one should not be a member by virtue of holding an office. It should consist of professionals in the field of pharmacy, pharmacology, clinical laboratory and industry. Ultimately it is the industry which has to give standards and we hope that representatives of the industry will assist in setting up standards.

How has the transition been taking place in terms of QA or QC among the industry?

Earlier it was difficult to get foreign approvals like USFDA for most of the companies. They want consultants to let them know how far the GMP is essential to satisfy the foreign requirements. Till recently much of our exports has been in the area of bulk drugs and hence the only inspection done by the foreign agencies were USFDA. Medium sized companies were not ready with their GMPs and they wanted me to tell them how they could go about it.

In 1988 with the implementation of Schedule M quite a lot of companies wanted to be GMP compliant. Today the exports are being done even for formulations and increasing number of companies are interested in getting advice for GMP for their formulations facilities.

How does the industry look at quality today?

Earlier, the industry did not have a systematic way of working. By and large, Indian companies suffered from poor documentation. Once the system were put in place, things started increasing and they realised that they got to build a name for quality. Unfortunately, the quality of students coming out from academic institutions is very poor. The few best are inclined to go abroad and the remaining are very much in demand and well paid. But the work they do is not satisfactory for the kind of money they earn.

What should be the priorities of the Indian industry to meet market requirements?

Productivity has to improve and labour laws have to be amended. Without any incentive to labourers’ higher production will suffer. Incentives to labourers and new technology in production are very crucial. There is also a need for better quality of supervision. Pharmacy education system is another area of importance. The syllabi is very outdated and they are not related to current method of production or today’s approach for new molecule research. The curriculum needs a drastic change and need more efficient teaching faculty. Today several retired industrialists are keen on putting up training institutes for various functions in pharma industry like quality control or production.

What is the potential for the Indian industry?

India has a huge market for non patented drugs. We have got to build up reputation for quality and timely delivery. Except for a few top companies, rest are not inclined towards new molecule research. Many products are coming off-patent and smaller companies should cash in on this opportunity.

What are the challenges for the Indian industry?

The Indian industry has earned a name for quality. But there is a need for firm commitment of managements to quality which is essential to establish a brand and protect it. With a lot of competition from small sector and price war, companies should be committed to quality for their own survival.