Shahid Akhter, editor, ETHealthworld spoke to Dr Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals India Pvt. Ltd and Chair- OPPI Technical & Supply Chain Committee to understand the need for standardisation of ‘quality‘ in the pharmaceutical industry. Edited excerpts :How do you define ‘quality’ in pharmaceutical industry?
Quality in general is a comparison to standards. For everything there is a reference point. If you see, in general, compliance to specifications is something we refer to as meeting the quality standards. Pharmaceutical quality is very specific because for each pharmaceutical product there are specifications for each product like a tablet or a capsule. And within tablets you have individual specifications for each individual product. There is a specification for each pharmaceutical dosage form and there is also a quality specification for each therapy area product and they need to comply to if you say that these products are meeting the quality specifications.
What are the quality trends that you see emerging across the globe?
I see a lot of focus on quality in different parts of the world. It means differently sometimes to different organisations in different regions. Quality for pharmaceutical product, in my opinion, should be the same for the patient is the same everywhere- whether it is a patient in India or US or Japan market. There are individual requirements for different countries. For example, in Japan, where my company which I work for exists, quality does not mean only the functional quality; quality also means the cosmetic quality. This means a tablet, or a capsule should also look perfect cosmetically other than the functional quality of the product. Whereas if you see, in the US, the compliance to specifications is the same as that for Europe and other parts of the world. So, the baseline is, if the product is meeting its pre-determined specifications, we say that the product is meeting the standard quality specifications.
There is a large amount of work going on in harmonizing the specific quality trends for individual countries and regions. For example, there are three main regions in the world that define quality- US, Europe and Japan. Regulators in these countries are also working towards āharmonisingā the specifications, while the product is moving in commerce across different barriers and different regions. So, when a product moves from India, for example, to the US market, it should qualify to the US quality specifications. Europe, has its own regulatory guidelines for quality and same is the case with Japan. There is a need to harmonise these specifications so that, at the end of the day, what we are doing is, we are testing the product as per US, Europe, Japan and sometimes if a company in India is manufacturing for three regions, they must test for all. The product also becomes expensive and it takes a long time for testing for all these three regions. There is an organisation called ICH which is the International Conference for Harmonisation, which is developing procedures and systems and common specifications so that there is a harmonised way of working as far as quality is concerned and as far as assurance of quality for a product is concerned in different parts of the world.
As of today, India is not compliant to ICH and India is also not compliant to WHO GMP specifications which is the baseline across the world if a pharmaceutical product must meet certain quality specifications. In India we have a guidance which is called Schedule M. Schedule M specifies what is required for each pharmaceutical product to meet various specifications; what we need to do as far as different processes are concerned and what are the assurance mechanisms built up in different products. There is also a new awareness which is coming up in India that we should graduate to the next level of quality and that is the first initiative that the Government has taken- to move from Schedule M to WHO GMP standard that will be the baseline standard because it is universally accepted norm if you follow WHO GMP standard. If we do not follow this standard, each organisation who wishes to export to WHO designated countries will need to have a compliance separately for WHO, get an approval, get an inspection done and then only be able to export to those countries. A common example is anti-AIDS products or vaccines which qualify to WHO specifications and then they are allowed to move into international commerce.
But if we graduate to a WHO GMP standard in India, not only is it good for the industry it is good for the patient because we are assured that the patient is being assured a minimum guarantee of an international level of quality which is followed everywhere in the world. So that is something which is going on right now. I recently interacted with the Department of Pharmaceuticals and other associations on how we graduate Schedule M to GMP and the Government is serious. Right now, awareness programmes are going on in India to talk to industry and create an awareness on what is the difference between WHO GMP and Schedule M. The difference is not much as of today but there is a difference in working and there are different standards that need to be followed for WHO GMP, which in my opinion we should be able to graduate to in the next couple of years.
What are the challenges in implementing quality in India?
I think one of the biggest challenge today is that there are diverse pharmaceutical companies. We have organisations which are best in class because they are qualifying to international standards like US, Europe and Japan and other parts of the world, that have stringent guidance. They are exporting. As we know, India is called the pharmacy to the world, that means, India exports a lot to these three regions. That also tells us that India is capable to deliver to an international quality. What we need to do is to harmonise these standards and bring those quality of products to India because India is very diverse. if you notice there are more than 10,000 companies in India. All of them do not follow the same standard. And that is the reason that even if they are generic products, two generics of the same product also not equivalent. They are different because they are manufactured under different quality systems. They comply to different requirements.
There are in-house requirements of each company. What you see today in the industry or if the patient goes out in the market and buys a product ā products of different companies, products manufactured by different companies are not equivalent. They may be the very basic requirement of only the availability of the drug in that particular tablet but how the drug behaves over a period of time- how much release is there in 30 minutes or 45 minutes or one hour depends on how the product is designed. Also, the benefit a patient derives from the product depends on the product design. So, all products are not designed in the same way. if the designs are different but the specifications are one, ten companies can meet the specifications, but the designs are very different. So, the patient behavior or patient outcomes could be very different. The world, be it US, Europe or Japan is moving towards āpay for patient outcomesā. So, if you get the benefit you pay if you do not get the benefit you do not pay. That is the kind of assurance level the world is moving towards. This means that companies need to graduate to a very high level of quality to assure the patient- to assure your performance in the product.
I would say that this is a big challenge for both the Government as well as the industry. How do we really come to a common platform and say that this is the basic standard of quality that needs to met by every product that is available in the market. But this is not the situation today. We have counterfeit products which is another big challenge as they are the illegal supply chain that exists at different levels. To track these illegal supplies effectively is the most important area of focus for the industry and also for the Government.
I would say the third area is affordability and access pf the products to patients. We as industry forum, for example, the OPPI, we make this as one of our make this one of our major objectives to make sure we create access to those products which are considered to be expensive. We follow a differential pricing model in India, we have several patient assistance programmes so that at the end of the day, the patient gets what the patient deserves. If they are at the bottom of the pyramid, they are not able to afford, many of our member companies have special assistance programmes to give the product free. Even my company does that. We give a product free to the patient if the doctor and the independent agency says that the patient is poor and cannot afford the product.
