India should focus on pharma intermediates self-sufficiency

India should focus on pharma intermediates self-sufficiency

India’s dependency on China for pharma intermediates can change if there is a proper coordination between educational institutes, research institutes and pharma manufacturers

  • By Dr. K. Nagaiah , CSIR-IICT, Hyderabad, Chief Scientist & Head - Centre for Natural Product and Traditional Knowledge | February 11, 2021

It is heartening to note that Indian drugs (mostly generic drugs) are being exported to 200 countries including the USA and European countries worth US $20.03 billion in 2019 but enough attention is not being given to the manufacture of basic chemicals like Tetrahydrofuran, Dioxan, Butyrolactone, Dimethylformamide, Dimethyl Sulphate, many derivatives of Pyridine, Methyl Acrylate and others. The large-scale manufacturing of these compounds involve vapour phase reaction, high temperature, catalysts like Aluminina Montmorillonites and zeolites long distillation columns. These are mostly carried by chemical engineers involving huge chemical reactors. Although some institutes are carrying out the application of new catalysts in this process, these are restricted to laboratories in gram quantities.

India is exporting generic drugs to many countries but the formulated drugs as tablets are facing rejections by USFDA because of human hair, glass pieces, contamination, change of colours etc. and these rejections are well documented. Even in India some popular generic tablets were of coloured coating while same branded drugs are colourless. It is clear some external impurities or lack of proper crystallisation is responsible to impart some colour to the drugs which are not coated uniformly.  

In a meeting 10 years back, a famous Indian organic chemistry scientist said that India lacks expertise to discover new drugs and the same holds good even today. To discover new drugs, a close coordination of life science scientists familiar with Biology (DNA, RNA, proteins and enzymes), virtual modelling, knowledge of Computer Science are necessary with Medicinal Organic Chemistry. Indian universities have never given emphasis on Biology, Microbiology and Genetics as teaching subjects and private universities that sprung off are just glorified engineering colleges where emphasis is on Computers, Artificial Intelligence (AI) and Robotics etc. which have no relevance to the Indian context.

Recent COVID-19 pandemic revealed that knowledge of Virology and Epidemiology in India is just rudimentary and only 3 to 4 national institutes are working on Life Sciences. It is clear that Life Sciences teaching and research needs to be improved so that Indian papers on Corona in international journals can be increased.

For pharmaceutical intermediates we are dependent on China. If a drug has eight steps of reactions, we are importing the sixth intermediate from China or other countries. It is evident from the recent COVID-19 pandemic that there will be a shortage of life saving drugs if there is a lockdown in China though our drug manufacturers give assurance that they have a stockpile of advanced drug intermediates for at least two years.

One silver lining for Indian drug manufacturers is that patients from advanced countries visit India for treatment. For e.g. Ledipasvir-Sofosbuvir a drug for Hepatitis-C is manufactured in India. The  treatment costs Rs. 60,000 while in advanced countries it costs Rs. 60 Lakh.

Telmisartan, Montelukast (life-saving drug) several NIBS (anticancer drugs, important examples is Imatinib), all antiviral drugs have several synthetic steps, at least these kind of drugs our industry need to synthesized completely from first step to finished final drug. In fact, 80 percent of the drug components are being imported from China, we have figures that US $2.405 billion i.e. 67.56% worth of drugs are imported to India in 2019.

It is the responsibility of the private drug industries to manufacture intermediates by taking the assistance of national institutes to provide cost effective and easy synthetic processes. The academic institutes like universities with lack of funds for research may not be able to contribute in this area. India is mostly manufacturing generic drugs, the production of corresponding intermediate may not pose any problems.    

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