In earlier years (1940s and 1950s) manufactured formulations were tincture spirits, pills and ointments. The pharmacy practice was centred to compounding the powders (prepared either from medicinal powders or by pulverising the pills) and dispensed in folds of butter paper. Students were even taught in pharmacy classes as to how to make a ‘neat paper packet’ for patients.
Manufacturing was centred in the eastern part of India, mainly Kolkata and few other towns of Uttar Pradesh (both having a strong presence of industry climate). This was probably because pharmacy education started in Banaras Hindu University (1950s). In Kolkata, Dey’s Medical Store used to be main retail pharmacy along with a few smaller ones. After retail dispensing and practising pharmacy, companies thought of manufacturing and producing some liquid oral preparations. Around the same time, few of the companies from western world (mostly the UK and the US) got attracted to India and set up their plants in India. Squibb chose western part (Baroda) while others like Martin & Harris and Organon set up plants in Kolkata and number of others were concentrated in Mumbai. This was in early to late 50s in the 19th century. Manufacturing in other cities also sprang up and a number of tiny manufacturing sites (again promoted by retailers and whole-sellers) produced mostly liquids and syrups to sell in the local markets and manufacturing license were also granted to these units.
The regulations
Conditions for granting license were mentioned in Drug Rules and were also mentioned in a separate schedule of the rules. A few details were mentioned in a separate schedule, a Schedule M of Drugs & Cosmetics Rules, which was then sub-titled as ‘requirements for manufacturing premises.’ Except few conditions such as minimum area needed and list of some machinery, it did mention about other details of pharma manufacturing.
Smaller factories manufacturing formulations were mostly located in residential areas . In SSI, the procedures were mostly manual or partly mechanical and a general cleanliness and hygiene was expected to be maintained.
Gradually few international medicinal products were manufactured here. Tablets and other formulations were manufactured mainly in western part of India. Penicillin was then a recent antibiotic and sulphonamides were anti-bacterial. Though penicillin was considered a sensitive medicinal product, the words ‘contamination’ and ‘cross-contamination’ were not common. Schedule M then, did not mention any of these conditions which need to be adopted by manufacturing sites. Multi-national companies operating in India followed their principle’s manufacturing document for safer products which mainly were manufacturing procedures (Manufacturing practices and operating procedures were not popular terms).
The progression
As years passed, product range also expanded. Antibiotics, hormones, anti-cancer and other very sensitive category products viz. corticosteroids, were being manufactured in form of oral preparation (tablets capsules and liquids) and parenteral preparations both. Bigger companies introduced manufacturing practices and operating procedures which later were called as good manufacturing practice (GMP) and standard operating procedures (US FDA further added the word ‘current’ as for them good was not enough).
GMP regulations thus have come a long way since its introduction in 1960 by Canadian Authorities which started as QUAD programme. In India, GMP acceptance spurred by serious events of contaminated IV Fluid in UP (BJ Pharma Kanpur) and Gujarat (Sanitex Baroda) in early 70s (1971 – 1975) resulting into deaths of a number of patients. Regulators here realised the dangers to patient community due to quality failures in manufacturing. They realised that poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. A poor-quality medicine may contain toxic substances that have been unintentionally added. A medicine that contained little or none of the claimed ingredient will not have the intended therapeutic effect. They realised GMPs as regulatory codification of generally known quality principles.
Since mid-70s, WHO has been supporting medicines...
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