Cough syrup Controversy: The World Health Organization (WHO) tested samples of Maiden cough syrup and found excessive levels of ethylene and diethylene.
Image credit source: telegraphindia
Cough syrup:Between October and December 2022, two Indian companies – Delhi Maiden Pharmaceuticals and Noida Marion Biotech – created by cough syrup May be responsible for the death of 87 innocent children in Gambia and Uzbekistan. At least both the countries have made this allegation. The World Health Organization (WHO) tested samples of Maiden cough syrup and found excessive levels of ethylene and diethylene. When the state pharma regulator of Haryana inspected the Maiden company, it found several lapses there. These included lack of testing of raw materials and wrong labeling of drug shelf life. The manufacturing of the drug has been halted in Marion following a joint inspection by state and central drug regulators.
Leaving aside the blame game and global pharma politics, these two incidents should make our policy makers take the matter seriously. Why? Because we cannot destroy the credibility of the producers (not necessarily including Maiden and Marion here). Undoubtedly, India is also known for the pharmaceutical industry along with the IT industry. With annual exports of around $25 billion last year, the Indian pharma industry is the third largest drug maker in the world by volume. In terms of value, we are at number 14. 20% of the world’s generic drugs (generics are cheaper versions of patented, innovator-company drugs) come from India.
America, the world’s largest pharmaceuticals market, gets about 40% of its cheap generic drugs from India. People like Dr. Anji Reddy of Dr. Reddy’s Labs, late Parvinder Singh of Ranbaxy and Yusuf Hameed of Cipla have built India’s global reputation. Hamid’s Cipla made life-saving AIDS drugs affordable for millions of people in Africa in the early 2000s. So, India has a lot at stake.
case of good construction
Medicine formulation (as it is called in the pharmaceutical industry) is a complex business. It includes different chemicals, each with its own complexities such as particle size, polymorphism, pH and solubility. These must be manufactured with great precision and high quality in order to make safe and effective medicines. That is why drug manufacturers need to follow Good Manufacturing Practice (GMP) under which specific steps are followed in the manufacture of drugs. Broadly these steps cover process validation, quality control and documentation.
There are more than 9,000 independent manufacturers of pharmaceutical formulations in India, of which more than 3,000 operate from less than 5,000 square feet of space. This means that their ability to comply with the demands of GMP is limited. But you should keep in mind that India is the only country outside America which has the largest number of US-FDA (Food and Drug Administration) manufacturing plants.
Now you can probably guess: With companies like Dr. Reddy’s, Sun Pharma, Cipla, and Torrent Pharma – all claiming to have US FDA-certified plants – we have many small manufacturers. Why do they exist? Because affordability matters when it comes to (life-saving) drugs. You can buy the same medicine from different manufacturers at different prices, from paracetamol, sildenafil citrate (used in Viagra) to insulin.
If the drug manufacturer follows GMP, then it will definitely have a more cost-effective structure. Hence, it can only meet the demand of those who value security and impact more than affordability. But due to poverty and insufficient awareness, usually such manufacturers do not have many customers. People usually want to buy cheap medicine. Now one may ask, when most drugs are sold by doctor’s prescription (what is called the “ethical route” in industry parlance), why do some doctors prescribe expensive drugs and some cheap drugs? This is because doctors are expensive and cheap too! If you go to a corporate hospital and take a consultation, the fee there is at least Rs 800, but the doctor in the slum ‘clinic’ charges only Rs 100 and gives you medicines free of cost. Unfortunately even in healthcare you get what you pay for.
From GMP of India to Global GMP
In today’s global world it is expected that all countries use the highest standards of GMP. The organizations certifying to the highest standards today are the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme or PIC/S which dates back to the 1970s and was established primarily in Europe for products to GMP and regulatory standards. But in 2011, the US FDA – America’s pharma regulator – joined the PIC/S, giving it more importance.
By becoming a member of the PIC/S, a country follows the same global standards of GMP, training of inspectors and finally inspection and certification. Once a country does this, other countries accept its observation. Today PIC/S has over 50 member states – the two obvious exceptions being China and India.
Why is India (we leave out China here) adamant? This is because, as mentioned earlier, our pharma industry is fragmented and the cost of conforming to PIC/S is beyond the reach of small pharma companies. She will be ruined. If many pharma companies shut down, there will be a shortage of jobs. Then it is also a politically sensitive issue. Six years ago, the Indian government appointed IMS Health (now part of the American company IQVIA) to assess how much adoption of PIC/S standards would cost the Indian pharma industry and how much money would be made back through exports.
Obviously the cost would certainly have been high, although the benefits would have been to export it and reach a bigger market globally.
Nevertheless, the Government of India has expressed its intention to join the PIC/S at the earliest. For this to happen, all the key stakeholders associated with the pharma industry will need to change. Regulators (at the Center and states), research laboratories, training schools and manufacturing facilities all have to be improved. There will also be the most important government incentive to become PIC/S compliant. The Productivity Linked Incentive (PLI) scheme is already in place in the Pharma industry. What India now needs is an incentive for small manufacturers to upgrade their facilities, train their workforce and invest in software for a limited period that would enable India to easily become a member of the PIC/S. Many creative solutions can emerge if there is political will.
If the pharmaceutical manufacturing facility in India is as good as what we find in Germany, Japan or America, then definitely the confidence of the consumers around the world in the medicines made in India will increase more than ever before.
(Disclaimer: The views expressed in this article are the author’s own. The views and facts given in this article do not represent the stand of News9.)
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