For the past few months, there has been an incessant mention of the name Tobinco Pharmaceuticals Limited, and the Food and Drugs Authority, in the media on issues that is debilitating in the industry.

Personally as a Ghanaian, I have every love for any Ghanaian entrepreneur, especially ones that have been able to reach the height seen by Tobinco, Ernest Chemist, Kinapharma, Kasapreko, KAMA, RLG and the host of others. 

The least I can do is wish them progress and great height to become multinationals like the ones we see in the global marketplace. Gladly, Kinapharma, Ernest Chemist and few others are already multinational in the making as they have spread in the West African sub-region.

Similarly, Tobinco Pharmaceutical Limited has taken such a giant step that will usher the pharmaceutical sector into a great contributor unseen to our economy. I have been to and seen the factory and I can only compare it to the ones seen in movies! At least that is what I have seen.  I have not in my life seen  such an investment into state of the art manufacturing plant than that seen at ENTRANCE INDUSTRIES, a subsidiary of the Tobinco Pharmaceutical company.

The Banter

FDA faults Tobinco pharmaceuticals for having imported GSUNAT SUPPOSITORY, anti malaria, whose mode of administration is through the anal. According to FDA, the product has not gone through clinical trials, a case the manufacturer-GVS BLISS, has not denied. The Company has paid in full the penalty to the breach. Then,   FDA requested for the withdrawal of the product and the company has since completed that exercise.

Then came another angle, EXPIRATION OF REGISTRATION OF REGISTERED medicines and UNREGISTERED MEDICINES  sold by the company of which according to the company, FDA is fully aware of, because the company has noticed FDA of their situation for a respite for it to Re-register  and manufacture   locally as a local brand. Had circumstances not changed, this would have been done in June, 2013- three (3) months clear before the case became public.

It is very expensive to register and re-register a drug. It cost about THREE THOUSAND DOLLARS a product and it is UNREFUNDABLE IF FAILED!

Banning of BLISS GVS

If one product of a company suffers a regulatory failure, must the whole production line, as imported into the country by Tobinco pharmaceutical , be smeared as fake, even if had faulted in re-registration , of which the regulator was fully in the known?. What a normal and a reasonable man will expect is to get the re-registration done so that progress was made.  

A similar case has happened in USA, of an Indian Pharmaceutical giant, RANBAXY, whose one product became a regulatory public issue in the USA.  The state USA did not banned that company on all its products that are distributed and sold in the US market, but that one and only that product. You can Google- it was reported in the India media on 7th November, 2013.

Again, stopping the company from continuous sale of BLISS GVS product was in order so as to get them regularized by RE-REGISTRATION. But banning the Bliss GVS from doing business in Ghana and hence Tobinco pharmaceuticals, is a deliberate action to caput the company. They (FDA) have seen that the company substantially sells their brands and so that act was to see a sudden collapse of Tobinco overnight. A pure PHD-pull him down syndrome. Period!

The Disclaimer

Somewhere in September, 2013, there was a publication in the media of some same UNREGISTERED DRUGS,  sold in the Ghanaian market and the FDA, disclaimed that it was not coming from them and hence a host.  The brands included strong branded and aged medicines, consumed by many Ghanaians and have been in the market for a very long time. The FDA asked the public to dispense that information.

Subsequent to that the FDA BLOCKED PART OF THEIR WEBSITE GIVING ITEMISED DETAILES OF VARIOUS REGISTERED DRUGS ON THE GHANA MARKET. Their reason was that people were downloading and adding their own list. How can a regulator state this to the public?

I WANT TO DARE THE FDA, TO PUBLISH THAT LIST OF WHOLLY REGISTERED PHARMACEUTICALS (MEDICINES) IN THE GHANAIAN MARKET!

 I want to restate my challenge to FDA and its officers to publish list of registered drugs in the country, if they are in honest and fair action against Tobinco pharmaceuticals. The action of FDA is beyond regulatory! I dare say it is a manhunt of the CEO of the Tobinco Company. Short and wide!

Several pharmaceutical companies have most of their drugs unregistered. Yet, the FDA has kept mute on them – just because they gave the BIGGEST FAT ENVELOPS. Why are these drugs not SMEARED AS FAKE!

Information making rounds that the company has several products, nearing one hundred unregistered. It is also in the rounds that the company has FDA Numbers to near hundred products and so who gave them these numbers?

The whole issue is confusing and the earlier we sit up to think and make a pharmaceutical giant from Ghana, the better.

What Regulator should have done

Instead of the regulator’s alacritic action by ramboing, seizing and calling all media houses to witness the destruction of Tobinco products, which was in very bad taste and more of a premeditated act to cause havoc and destruction of reputation. It also seems to have been carried out by overzealous minds without any depth of thinking. They could have done these suggestions, and I think this is how a reasonable man ought to regulate:

1. Call for withdrawal of all such products from the market.
2. If there is or was a penalty, the company must suffer it.
3. No resell until all irregular actions has been regularized.
4. And then company allowed to hit back in the market with the regularized medicines.  

This is what the USA authorities did to RANBAXY pharmaceutical of India in the USA market and it was a very reasonable action!

Can we see any sanity now? Wisdom must prevail.

The writer loves Ghanaian businesses thriving.