India is exporting several drugs, formulations, a creditable achievement. However, there are several short-comings: The drug manufacturing in India is not total form basic chemical to fine chemicals.  Our pharma sector is largely dependent on China or other countries for the imports of basic chemicals, reagents etc and advanced intermediates. In fact, when a drug synthesis involves 8 or 9 synthetic steps, we are importing the advanced intermediates. Only our drug manufacturing scenario involves the last step synthesis only.

Formulations scenario: It is a big news in newspapers if our pharma export formulations to USA.  However, some formulations are being rejected by USFDA due to failure in quality control, which include colour change, divided finely presence of human hair, glass pieces and many other reasons. USFDA website gives all the above information, including issue of warning letters. USFDA officials found, GMP is not observed when they visited manufacturing sites.

Generic verses Branded drugs: Govt. of India is encouraging manufacturing under generic name with affordable price tag. Some doctors encourage or prescribe generics. However, some doctors insist only branded drugs. A serious study about their relative efficacy is needed.  This could be done by pharma colleges as research projects are by central chemicals institutes. This kind academic joint collaborative study is needed. Drug testing authority don’t seem to have taken interest in this area.

Combinations of plant extracts/vitamins/animals or aquatic organisms extracted products sold as drug: One example cited here is there are many of such products in the market. The concern here is corporate hospitals are prescribing these drugs which have very high price. How the combinations are approved by whom, any studies are made before releasing.

Then only “Aatmanirbhar Bharat Abhiyan”, the policy of Government of India for “Make in India” is possible.

Some small drug companies’ formulations are sub-standard: A few small companies are marketing in rural areas some substandard or sometimes only simple chalk powder in capsules.  Many stray reports are appearing in newspapers.

Collaboration of pharma sector with pharmacy and chemistry divisions of universities and Central Govt. institutes: The pharma Industry may sponsor schemes to the above institutes to study quality control aspects of generic versus branded drugs by double blind study, includes percentage purity, identification impurities (impurities profile) by HRMS, HPLC/MS/MS. Further the drug synthesis of expired patented drugs may be assigned to chemistry division of universities/ central institutes who report their reports to sponsored company. This is in addition to their independent synthesis of the same drug R & D division of pharma company and choose one route the best one. For this purpose Universities, National laboratories and Pharma R&D  should work together in reducing import dependent on China and other countries manufacture right form basic chemicals, fine chemicals and advanced drug intermediates.

R& D division of pharma companies need to revise their policy: So far it looks the R&D of pharma is confined and oriented to drugs they are manufacturing. The pharma is dependent on literature internet from patents. They do not possess the latest text books/monographs/chemical abstracts (CA). The literature study is extremely useful to synthesis advanced drug intermediates. It may be pointed out here that almost all the advanced intermediates were already synthesised for different purpose, well before 1985 year. Lack of journals (like J Medicinal chemistry etc.) in the pharma sector laboratories is a big impediment for pharma R&D labs. At least in Hyderabad universities and central institutes have well equipped libraries for this purpose. In fact, the strong suggestion is at least 2% of R&D staff money should be spent on fundamental organic research to improve the skill sets of their chemists. 

Starving of Forex if basic chemicals synthesised in India itself: This is a must not only to conserve forex but also for few other reasons. Self-dependency is a must. During covid season, some public worried, that lifesaving drugs may face scarcity. It is a matter of relief that pharma companies stocked advanced intermediates sufficient for another year.

Especially for synthesis of basic chemicals, the industrial processes are different form laboratory procedures. For industrial process of basic chemicals like dimethyl sulphate, dimethyl formamide, dioxan, tetrahydrofuran to mention few) high temperature vaporisation, silica-alumina oxide catalysts and large distillation under vacuum is necessary. Advice here in encourage recruitment of chemical engineering experts, infrastructure to be built up and at least each big pharma may specialise synthesis ten basic chemicals for Atma Nirbhar Bharat in addition to usual their drug manufacture.  Thus 100 big pharma  to 1000 fine Chemicals  for Atma nirbhar programme for Indian and export need.

Some dark corners in the export of formulations: Although the drug exports doubled during the last decade but undesirable events happened during last year. Four contaminated cough syrups exported to poor countries of African “caused acute kidney disease, linked to the deaths of 66 children’s in the Republic of Gambia”. One incident is enough to destroy all our good performance of entire Indian Pharma.

Packing of drugs into strips:  The expiry date of almost all strips is rubber stamped vanish in a matter of 3 to 4 months, making the remaining tablets waste for subsequent use before expire date. It is a serious matter which require the attention of all pharma.

Request to Indian pharma: Please produce drugs for Indian specific tropical diseases like malaria, tuberculosis and dengue etc.,

Fire accidents in chemical/pharma industries:  In summer may fire accidents took place, leading in some cases death of cookers and loss to pharma companies although short circuit is cited as reason, the fact remain the accidents are mainly due to employment of illiterate migrant labours, who don’t know volatility and inflammable nature of the solvents (see our article Down To Earth) using the company.

Chemical testing where some pharma companies if involved and unethical testing of foreign sponsored schemes on clinical testing: Reports are found that some migrant construction workers and Khammam Dist. Girl tribal are the target. Request is to avoid unethical clinical testing is to banned (see our article in Hans Newspaper).

These are issues few only, which should be corrected by drug manufacturing companies by self-assessment. These short coming discussed above if corrected, we could achieve Atma Nirbhar Bharat in the drug industry will be highlighted in the present “The NextGen Chemicals & Petrochemicals summit 2024” pharma meeting.

At the end the message is self-assessment, self-correction is a must by pharma instead being assessed by USFDA, or India CDSCO (Central Drugs Standard Control Organisation) Govt. of India Drug Regulatory Authority.