From CPHI India

Eager-to-please Indian manufacturers creating GMP chaos says expert

By Fiona Barry

- Last updated on GMT

A promise is a promise
A promise is a promise

Related tags: Indian companies, United kingdom, India, Pharmacology

Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.

Bharat Shah, founder of Sigma, which imports medicines into the UK, said generic shortages have “become a nightmare in the UK,​” causing “suffering​” to patients.

In the last two years India has seen “a lot of issues with GMP compliances, especially for Europe and the US,​” he said at the UBM India Pharma Awards in Mumbai last week during CPHI India.

Most UK suppliers will tell you one problem we have with a lot of Indian companies is they make promises and do not deliver properly.​”

The problem is “cultural​,” said Shah, originally from India and now head of UK-based Sigma, speaking afterwards to in-Pharmatechnologist.com.  

The classic thing in India is these guys will never say no. You will say to them, ‘I need this done,’ and they’ll say ‘Of course.’​”

The result is delays and frustration from buyers, he said.

UK regulator MHRA told in-Pharmatechnologist.com it is “not aware of receiving a serious or fatal ADR [adverse drug report] as a result of a generics shortage​” but the issue is worrying parliamentarians.

The All-Party Pharmacy Group warned of low stocks of branded and generic medicines in July this year,​ saying that although the problem was “less visible​” than two years previously because of hard work by domestic chemists, “the problem is far from solved.​”

Generic uptake is high in the UK, where the biggest buyer by far is the National Health Service.

‘Too hospitable’?

Shah added that Indian drugmakers are being hampered by their friendliness – and suggested they adapt to suit British mores.

The second cultural thing is they’re too hospitable, they’re overpowering. Sometimes in business we find that people then want to keep a distance.

In India and China if you meet somebody and you want to do business, you have to [first] go for dinner.​”

He suggested “maybe they need to take lessons​” on UK culture, just as the British Council gives lessons on settling in to foreign students arriving in the UK.

A more widely practised solution “that a lot of Indian companies have been successful with is finding partners in England, France Germany to become their front.​”

Sigma is one such company. Shah says the firm partners with Indian companies and acts as a go-between for European buyers.

Within five or six years, these Indian companies learn enough about British expectations to go it alone, but the steady influx of small and large Indian contract manufacturing organisations and innovative drug companies wanting to do business in the UK keeps the model going, he said.

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