DR KOMMU NAGAIAH

CHIEF SCIENTIST & HEAD - CENTRE FOR NATURAL PRODUCTS AND TRADITIONAL KNOWLEDGE, CSIR - INDIA INSTITUTE OF CHEMICAL TECHNOLOGY, HYDERABAD

SKILLED MANPOWER CHALLENGES IN INDIAN PHARMA

Drug industry should provide appropriate training to personnel working as chemists in drug synthesis and analytical chemists

Many of the drug industries have R&D laboratories but corresponding library facilities are lacking. Nowadays literature survey is being carried out via the internet - Reaxys, Scifinder, MedPub, Patent search. However, these internet surveys are supplementary but not complimentary to Journals. Bielstein, Gmelin, Dictionary of organic compounds and chemical abstracts from 1906’s, standard monographs and books are a must for a library. Often these R&D laboratories are mere development laboratories for a trial synthesis of generic drugs before going to manufacturing/ production. And here also the research component is missing. So far, no new drugs are developed in India nor industry has any plan for new drug discovery. Apart from the organic synthesis of biochemistry knowledge topics include DNA, RNA, proteins, enzymes, hormones, etc. The challenges of new drug discovery involve medicinal chemistry which means a constant dialogue between chemists and biologists, including computational studies is necessary. On the web internet, the 3D-structures of many enzymes and proteins which cause diseases are available. A virtual study involving many organic molecules (gener-

India has become a generic drug centre since it exports ated on a computer) and at which docks drugs to all countries. During COVID-19, India export- protein enzyme. Thus by hydrogen ed Hydroxychloroquine to Brazil, the USA and other bonding, docking studies or molecular countries. Presently, India is exporting COVID-19 vac- modelling or receptor-ligand interaction cines to many countries globally but the Indian drug will be the first step. Such studies in Inindustry often complains they are not able to recruit skilled dian drug R&D centres are not-existent chemists as universities do not train students to make besides regular laboratories necthem industry-ready. “Drug essary to conduct pharmacy

If we look at the curriculum of our univer- industry and pharmacological, sities with chemistry reference, they cover should make some pharmaceutical studies. typical branches like organic, inorganic and kind of consortium to The recent pandemic physical chemistry. On the other hand, the teach additional subjects revealed we don’t have

Indian drug industry has to provide addi- on the synthesis of drug enough life scientists tional training in the concerned branches of development, name and biochemists, viorganic chemistry like drug synthesis which reactions, a literature rology and epidemiolincludes practical experiments also. search on experiments ogy as unfortunately Not only this, the drug industry should suitable to drug many universities don’t also form a consortium to teach additional sub- synthesis” have these courses. jects on the synthesis of drug development, name For a new drug discovreactions, and literature search on experiments suitable ery laboratory, the assistance of for drug synthesis. Even if they recruit PhD’s for the job, they life scientists is a must. For a new drug have to be provided specialised training. synthesis series of compounds taking

leads to form natural products, SAR, molecular modelling or at least a “Me Too Drug” is the first step.

A good research paper, consisting of the synthesis of at least 60 compounds with biological activity must be generated for publication in “Journal of Medicinal Chemistry” or some other high standard journal. One of the compounds in that research paper may be a future drug. Such publications enhance the reputation of the drug industry or institutes. Usual procedures of international

patents may be adopted. An eminent scientist of India remarked India has no expertise to discover new drugs that hold even today. With these deficiencies in the drug industry, it is not possible to discover new drugs.

In India, even generic drug manufacturing involves the production of the last two steps out of eight steps of drug synthesis. The drug intermediates (step 1 to step 6) are exported from China or some other European countries. Many drug industries give only coded compounds with procedures to perform further steps by different methods in their R&D laboratories. With such a scenario, the chemists have no opportunity to improve skillsets even after 10 years. Without basic research, a scientist cannot perform well in applied research, drug research and drug manufacturing and in fact, he cannot tackle any problems mentioned in this note. Pharmaceutical aspects of drugs are also other activity.

On top of it, the management includes R&D directors who put a lot of pressure on chemists to improve skillsets to demonstrate higher yields with 99.9 per cent purity. Vexed with the scenario, chemists change jobs to nonchemical sectors or some other drug companies. Looking at the quality control point

“For a new drug synthesis series of compounds taking leads form natural products, SAR, molecular modelling or at least a “Me Too Drug” is the first step”

of view they import sophisticated instruments like NMR, HPTC/MS etc. for USFDA requirement. The operators of the instruments lack enough theoretical knowledge, the intricacies and the theory behind the techniques. There is nobody to teach them, once again the exodus of analytical chemists start. There are no instances where the management sends their chemists to seminars/workshops but there may be some exceptions.

The Indian drug industry made a name in producing generics, but countries of this size must aim further to discover new drugs. The skillsets of chemists can be acquired as per the demand, provided appropriate training is given.

Skilled Manpower Challenges in Indian Drug Industry

The challenges are: Speciality chemicals production; Developing winning strategies in production; Developing high quality and low-cost pharmaceuticals; Reduce imports of raw materials, intermediates and APIs; Manage safety and regulatory aspects of chemical products; Knowledge of chemistry, chemical hazards and safety measures; Documentation of process activities; and Production of intermediates by following SOP.

Indian drug manufacturers need to relook at the performance, for example, everywhere there are complaints about pollution - leakage of gases, pollution of water bodies with traces of drugs, heavy metals like Cd, Pb, As, Hg, etc., and frequent fire accidents. Usually, unskilled labour is transferring chemicals from one place to another place, loading the reactor, with chemicals filtrations and washing. These are the places, where fire accidents are reported in the Indian chemical industry. Indian drug industry should provide appropriate training to their staff working as chemists in drug synthesis and analytical chemists.

In the very selection of sites for chemical/drug industries, the intervention of environmental engineers, environmental chemists are a must. The chemistry of industries should depend on wind direction. The nature of the soil is also important so that the effluents do not percolate into the soil. Of course, the selection of industrial estates should be far away from human habitation, but in course of time colonies sprung up strangely the industries never protest. Examples are many, Bhopal gas tragedy, Vizag styrene gas tragedy would not have happened, so severely if the human habitation were not there in Vizag the pharma city is near the sea, where cyclones are very frequent.

Environmental conditions are never considered. The course work on environment subjects must be strong at the university level and industries should employ them to predict environmental hazards otherwise the industries suffer and there is the closure of industries.

Pollution monitoring of air carbon dioxide, nitric oxide, water (pesticides and toxic elements) need to be the topmost agenda of chemical industries. The activities need to be guided by expert laboratories and scientists and methods to control pollution should be an important priority for industries.

Chemical Engineering and Technology division should undertake pilot plant studies, chemical designing of equipment reactors, heat exchangers, condensers, storage units, fire safety and environmental aspects so that the engineers can advise on chemical manufacturing be it project reports, production, turnkey, troubleshooting and selection of equipment. The real growth of industries lies in the development of indigenous synthesis and technology.

Universities should tie-up with industries and scientific institutes in the country. The role of the universities is to provide M.Sc. courses and provide conventional experimental training with the help of industries/scientific institutes. The role of industries is to develop New Chemical Entities (NCEs). The trained chemists when they join the industries will acquire skillsets of drug discovery and synthesis of many NCEs for new drug discovery which is missing in the Indian chemical industries.