Kerala State Drugs & Pharmaceuticals (KSDP), a State-owned drug manufacturing company, is joining the ‘Vocal for Local’ bandwagon as it charts out a customised track regarding domestic production of Active Pharma Ingredients (API), the effective component in medicines production.

The Covid-19 pandemic and its aftermath has necessitated the drug manufacturing company to think along these lines especially as API vendors are predominantly from China, Vietnam, and Korea, more so in the case of antibiotics and oncology medicines, says S Syamala, Managing Director, KSDP.

Making life-saving drugs locally

The company has issued a concept paper proposing a project either by the government or a joint venture, keeping in view the issues associated with the import of APIs for some vital medicines. She emphasised the need for an API-focussed local manufacturing policy for life-saving drugs.

There are serious hindrances in sourcing and arranging logistics for the raw materials in the Covid scenario. The non-availability of imported raw materials has already increased the API cost of Azithromycin to around ₹17,000 per kg from ₹8,000, she adds.

The break-up of production costs of medicines indicate that the APIs contribute to as much as 50-60 per cent. APIs like Penicillin, antibiotics like Azithromycin, oncology drugs, NSAIDs like paracetamol, allergic drugs like Chlorpheniramine Maleate, Cetrizine Hydrochloride, anti-hypertensive, and drugs like Losartan Amlodipine, an anti-diabetic drug like Metformin Hydrochloride, Glimepiride hits the list.

Need for other components

Along with API, the formulation industry requires excipients like tablet binders (Starch, Gelatin etc), lubricants (purified talc, aerosol etc), anti adherents (magnesium stearate), upper dis-integrant (sodium starch glycolate, Indion, croscarmellose sodium), sweetener (sugar), preservatives (Methylparabensodium, Propyl paraben sodium) and tablet-coating materials also hit the prime position.

Besides, empty hard gelatin capsules, PET/Glass bottles, vials, ampoules, primary packing materials, cartons are also required. In this way, the drug formulation industry is a consumer of a wide range of components. However, there is a need to consider various factors before going ahead with API production. It all depends on the availability of the latest, cost-effective, least polluted, and less time-consuming technology, she adds.

MP Sukumaran Nair, former chairman of public sector Restructuring and Internal Audit Board (RIAB Kerala), noted that the Union Cabinet had approved ₹10,000- crore incentive-based scheme to boost domestic manufacturing of APIs by setting up bulk drug parks partnering with the states.

KSDP should take advantage of the scheme, as the Centre’s focus is to encourage domestic manufacturing of APIs by creating a suitable ecosystem and procedural support to pharma companies to kick-start production of intermediaries. He pointed out that erratic Chinese supplies provides an opportunity for the Kerala public sector company to go ahead with its plans.

Quoting figures, he said that API imports for the pharmaceutical industry was worth ₹17,400 crore in 2019. Prior to the opening up of the economy in 1991, the country imported only one per cent of pharma products, which now stands at 80 per cent.

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