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It’s time to be more vigilant and quality conscious

Dr Ashok Omray, Advisor Pharma Operations, Ex AVP, USV and Ex-President, ICPL shares how crucial it is to ensure that quality standards are met and sustained in the pharma industry despite any challenges or crisis faced

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Medicines are essential supplies to mankind. All efforts are being made to ensure that all the necessary drugs are supplied to the needy without any delay or extra price. But, recent times have been very difficult and the total focus seems to be on COVID 19. The good part is that for COVID 19, the governments and health authorities are directly involved.

Tough times

But, the lockdown since March 25, 2020, put restrictions on all types of transportation (road, rail, sea and air) has created a serious state. Manufacturing of drugs also suffered extensively due to the want of manpower, raw materials, packaging materials and a host of other things. The movement of inventory goods also suffered severely.

Though drug companies were given preference and relaxations during the lockdown most of the small and medium companies (MSMEs) could not work at all. With social distancing, strict hygienic practices and with only one third or just 50 per cent of the workforce, production activities could not be streamlined. At the same time, there was a need to ensure that our practices and standards are not compromised anywhere because of some exigency.

A great responsibility

We had been watching that in the last couple of months, the CDSCO and State FDAs have taken a lenient view and supported the drug industry by way of quick approvals, an extension of WHO GMP validity, importation of drugs with lower shelf life, quick clearance from the seaports and airports, licence approvals and product permissions. This leads to a greater realisation of the responsibility on the part of drug manufacturers. The drug industry, apart from the regulatory requirements, needs to work with a lot of self- imposed discipline, manufacturing practices, quality assurance and quality control practices.

We are aware of the level of automation, the level of experience and concerns of the employees in relatively smaller units, which are today the biggest source of formulations outsourcing by way of loan licence, third party or P2P arrangements. But, with limited space and a semi-skilled workforce, following the norms of social distancing and still manufacturing pharmaceuticals is a real big task.

Thus, business and productivity have to go hand in hand to maximise benefits in the pharma industry. Considering that we are into a lifesaving profession and sell our products in the international markets, we must not take any short cuts and not deviate from SOPs, quality checks and ultimate compliance. My message is more relevant for companies who outsource their products. Due to slackness on all the fronts, there is going to be supply constraints and due procedure of approved vendors, testing, the release of materials must be followed. The basic concepts of OOS and OOT must not be compromised. All of us are responsible for the ultimate quality of our products. So, if the quality is compromised, a blame-game will neither absolve us of our accountability nor will it erase the stigma or the negative image of the company.

Compromise in quality: Not an option, ever

In 2020, if I am talking all this, it means that despite the position we enjoy in the global market, internally we still follow different standards of quality. As a layman, compliance with the monograph is not the benchmark for our defence. We are fully aware that the procedure for the destruction of expired materials exists in the quality manual, but how long it takes to make a decision. Most of the instances cited above are from real-life experience.

People are not happy with the shelf life or expiration of materials even up to five years. I fail to understand why if the material cannot be used in five years then the same is purchased in a quantity beyond its estimated use. Simply the rate deal is the reason but greed has no end. The intention is not to point fingers on anyone but to emphasise the need for extra vigilance and quality checks during these times. We must not compromise with the standards and the CGMPs for the sake of urgency and business. No matter how hungry you are, you will eat well-cooked food only, isn’t it?

It is really a great deed to supply quality medicines to the user at a time when it is needed. During such a crisis, our approach must not be compromised and efforts must not get diluted.

People, otherwise, will question why the same products from different companies are sold at different prices. Do the patients have the flexibility to buy the cheapest available product on the doctors’ prescription?

Drugs are not just commodities and we must respect this hypothesis.

Let us be proud of our products, quality, practices and profession, especially during a crisis like COVID 19.

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