A few days back in a stakeholders meeting, a senior medical colleague raised a very important issue that pharmaceutical companies have two different types of plants; one, where they manufacture drugs for export and second, which manufacture drugs for sale in the country.

For indigenous manufacturing and supply, they only rely on Good Manufacturing Practice (GMP) certification.

But for international supply, they also comply with the stringent United States Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) certification standards.

The question then came up as to why the two plants are different. At first, I was not able to understand why but then I recalled that a hospital in Delhi never believed in expansion on the grounds that it was easier to get National Accreditation Board for Hospitals & Healthcare Providers (NABH) and Joint Commission International (JCI) certification with fewer beds than with a large number of beds.

Probably, for the pharma industry also, the requirement of exported drugs is limited therefore they can maintain high standards. But when it comes to supply of the high volumes needed in the country they will not be able to meet high standards and repeated inspections. Or, do profits come into play here?

This may or may not be right; but, this is a reality.

If pharmaceuticals can manufacture drugs of international quality, why shouldn’t the same quality be available to consumers within the country? There should be no discrimination in the quality of drugs produced.

Any suggestions from the group?

   Suggestions so far

1. You have raised a very important issue. This cannot be accepted. It is going on for very long time. Not only drugs but many utility items are manufactured in this way. When you go to buy, sellers proudly say that it is export quality and so they charge more. Drug controllers attention must be drawn to this discrimination. Dr R. D. Dubey

2. In agreement KK that there should be no difference in quality: Dr Shubnum Singh

3. I fully agree. I am glad you have brought this up. Whenever I have raised this issue, I am always told to keep quiet as they say we go merely by the requirements of the different regulators. In Rome do as the Romans do. So, they believe that if the DCGI is not as strict as the US FDA or EMA, why should they bother? And hence they believe they are meeting the requisite regulatory requirements in different countries. But I fully agree with you. Why can the company not have the same stringent quality standards for their products all over the world, as it should be with a multinational Indian company which has standard operating procedures, whether they market in Timbucktoo or the US?Anyway, now that you will take up the issue, I am sure something good will happen to harmonise the standards. Another reason could be that they market the exported generic to major markets at higher prices, get higher profitable revenues, and so have to and can afford to invest in state-of-the-art US FDA approved manufacturing plants. In India they market the generic at much lower prices and hence feel they can’t justify the same investment when they market in India. Differential or double standards? Viraj.

4. What has to be examined is the reasons for differences in the National and global requirements. How does it serve the needs of efficacy and safety? Some of the requirements are reactively added and then they just stay. An obvious example is bureaucratic layering of rules, which over a period of time become the SYSTEM itself and then begins the process of shortcuts and circumvention - the necessary evil of compliance - conformance systems which are static. The above is to set the ball rolling. Dr Akhil K. Sangal

5. The problem in pharma is the same as in many other regulations - we have not adopted international standards like WHO GMP in pharma and continue with lower standards on the plea that much of our domestic industry is unable to comply with international standards. This needs to change. We need to adopt international standards in our regulations and provide a time frame for industry to upgrade. Anil Jauhri

6. Not only export and national batches differ in quality. Many years ago, we had done a drug content study from private and public sector pharmacies. There were significant differences in the drug contents of various antibiotics. Dr Yatin Dholakia

7. Srekumar Pillai:  At last you said it. You can’t give cheap quality drugs in the name of volume. Government must assure quality for its nationals than “internationals

8. From what little I know and from the experience of overseeing Aurolab, I have come to realize that - Not all quality standards lead to enhancement in quality in all situations - USFDA and such standards significantly increases the cost, both in investment and in running expenses. Having said this, quality shouldn’t be compromised. We as a country need cost effective and quality medications, and I believe GMP standards do assure them. With Warm Regards, Thulsi

9. Greetings from Bangladesh! I find many units here manufacturing pharmaceutical products are now compliant with WHO GMP and USFDA and others. Similarly in India many companies are compliant but unfortunately our Drugs and Cosmetic Act Standards are not harmonised with WHO USFDA and others due to which several companies are able to escape. We urgently need to harmonise and there is a need to do that globally similar to Codex Alimentarius Commission. A beginning has started under International Council for Harmonisation (IHC). Hopefully we shall soon see common manufacturing lines for exports and domestic consumers in India. CDSCO and WHO are working with all the pharmaceutical associations on such issues. QCI has also agreed to work with MoHFW on such issues. Bejon Misra

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA