The local pharmaceutical industry has been given a big boost following the government’s decision to ban the importation of 49 medicines which have now been reserved for local manufacturers.
Noticeable names of medicines on the list include aluminium hydroxide or magnesium trisilicate suspension, amoxicillin capsules and suspension, aspirin or caffeine tablet, folic acid tablet, cetirizine tablet, co-trimoxazole tablet, diclofenac tablet, magnesium trisilicate suspension and tablet and oral rehydration salt (ORS).
Others are paracetamol syrup, paracetamol tablet, paracetamol or codeine tablet, simple linctus syrup, vitamin B complex tablet and multivitamin tablets (vitamins A acetate, B1, B2, B12, D3, nicotinimie, calcium pantothenate), Ibrufen tablet and cough mixture that contains carbocisteine diphengydramine, gualfenesin or ammonium chloride as a single ingredient.
No new registration
A copy of the gazette Executive Instrument 181 (E.I. 181), dated May 10, 2017 and signed by the Minister of Health, Mr Kwaku Agyeman-Manu, and copied to the relevant health authorities, including the Foods and Drugs Authority (FDA), the Parliamentary Select Committee on Health and the Ministry of Trade and Industry, obtained by Graphic Online, listed the 49 medicines.
This means that the FDA would not accept new applications for the registration of a medicine on the restricted list, the document said.
However, medicines registered before the implementation of the restriction would continue to be imported until the registration period of the medicine expired, it said.
Additionally, applications for the registration of a medicine on the restricted list which were already with the FDA before the implementation of the restriction will be accepted by the authority and taken through the requisite registration process for marketing authorisation to be either granted or denied.
Those granted authorisation will be allowed to import the accepted medicine until the registration period expires.
The restriction will, however, not apply to an innovator brand of the medicines indicated on the list.
The document attributed the decision to the fact that “the local pharmaceutical industry is developing and has gained enormous capacity, both in production quality and quantity, to produce a certain category of medicines”.
The action by the government is in compliance with the Africa Union’s (AU’s) Pharmaceutical Manufacturing Plan for Africa which aspires to strengthen Africa’s ability to produce high quality and affordable pharmaceuticals across all essential medicines to contribute to improving health outcomes and the realisation of direct and indirect economic benefits.
The plan was endorsed by Heads of State and Governments at the AU Summit in Accra in 2007.
Ghana intended to use the local pharmaceutical industry to secure its medicine related needs to improve access to essential medicines and in the process create jobs for Ghanaians, the document stated.
Too much import
Currently, there are 38 pharmaceutical companies in the country, with 210 others purely importing medicines, in an industry estimated to be worth at GH¢1.18 billion in 2015 and GH¢1.36 billion in 2016, according to statistics from the Ghana Chamber of Pharmacy (GCP).
According to the GCP, the local manufacturing industry produced only 30 per cent of the country’s medicinal needs, with a little over GH¢900 million going into importing the medicines.
The move was initiated by the Mahama administration with, the former Minister of Health, Mr Alex Segbefia, signing the gazette notification on December 23, 2016.
The gazette stated that the Minister of Health constituted a committee made up of the ministries of Health and Trade and Industry, the National Health Insurance Authority (NHIA), the FDA and the Pharmaceutical Manufacturing Association of Ghana to review the restricted list and recommend a new list of medicines to be restricted from importation and reserved for local production only.
The committee’s recommendations were subjected to broad stakeholder consultations with stakeholders, including parliamentarians and importers of the medicines recommended, and the list was submitted to the Minister of Health.
According to the document, restriction of the selected medicines would not affect the supply and availability of medicines in the country.
The move has been applauded by the GCP, whose Chief Executive Officer, Mr Anthony Ameka, described it as welcome news that will boost the industry.
He said the decision fitted into the chamber’s strategic plan to boost local medicine manufacturing and distribution, noting that the chamber and the manufacturers had worked with the FDA on a proper assessment of the capacity of the manufacturers and their ability to meet the standards required.
He said the list could have been tall but it was reduced because of capacity issues, but was quick to add that the list would be reviewed on an annual basis to increase the number of medicines on it.
“This will make medicines cheaper and available,” he said.
Already taxes on imported medicines and raw materials for manufacturing medicines have been scrapped.
Last year, the Mahama administration granted local drug companies, through the Export Trade, Agricultural and Industrial Development Fund (EDAIF), about $26 million to help expand their businesses.
Mr Ameka said the support had empowered the companies to work towards good manufacturing procedure certification given by the World Health Organisation (WHO).
He said the chamber was working in close collaboration with the FDA, which did a lot of market surveillance, to ensure that medicines put on the shelves were efficacious and met the required standards.
He urged the government to give a semblance of the mobilisation fee it gave to road contractors to pharmaceutical companies.
“If the government can look at giving us 50 per cent of the cost of the contract and then the remaining 50 per cent after the delivery of the medicines, it will give us a good boost,” he added.
He also made a strong case for cheaper credit for the industry, saying at the current 36 per cent, interest rate could not keep the manufacturers in business.
Mr Ameka also had issues with the delay in payment for drugs supplied, where it took more than a year for medicines supplied by distributors to the hospitals to be paid for, adding that it was taking its toll on the manufacturers.
Source: Daily Graphic
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