On Friday, the Department of National Health Services, void SRO 1347 (1) 2021 as of October 15, 2021, released a revised long-awaited contract manufacturing policy for the pharmaceutical industry. The objective is to allow the industry to develop synergies through subcontracted manufacturing agreements. This is considered a major achievement by the Pakistan Pharmaceutical Manufacturing Association (PPMA) which has pledged to quadruple its exports, crossing the billion dollar mark, over the next five years.
The new contract manufacturing policy was approved by the federal government at its cabinet meeting after extensive deliberations with pharmaceutical manufacturers. Tauqeer Haq, the outgoing president of the PPMA (PDG Santé Pharma) and Jalal ud Din Zafar, (chairman of the technical committee of the PPMA and senior general manager of the Nabiqasim & Surge Pharma group) played an important role in convincing the ministry officials of Health, Pakistan Medicines Regulatory Authority (DRAP) and Ministry of Commerce that this policy will help build the capacity of the industry.
– Jalal uddin Zafar (@ Jalalz75) October 16, 2021
Government views pharma as an industry with export potential
Pakistan’s pharmaceutical industry is small compared to regional giants like India and China. Its domestic market is worth around US $ 3.5 billion (PKR 550 billion) and its latest export figures range from US $ 250 million to US $ 280 million, far less than textiles and information technology. However, it is a knowledge-intensive industry that has grown steadily over the past two decades and government experts have assessed that the industry has significant export potential – if it is. encouraged by the right policies.
Imran Khan’s government is eager to increase the country’s exports; and with this new policy, it aims to strengthen the confidence and capacity of domestic pharmaceutical producers, encourage foreign investment and pave the way for pharmaceutical industry investment in new FDA / MHRA approved facilities and EU GMP. Advisor to the Prime Minister on trade and investment, Razzaq Dawood became a strong supporter of export-oriented businesses in the federal cabinet and, according to industry sources, his support was crucial.
The new 2021 contract manufacturing policy defines a strict relationship between what it defines as “contract giver” and “contract acceptor”. It has lifted previously imposed restrictions on the number of products allowed for contract manufacturing by the “contract giver” and will now allow companies to obtain as many products as expected manufactured under a contract manufacturing agreement. . However, the new policy still limits the engagement of the “principal” in the manufacture of pharmaceuticals, and the concept of authorizing contract manufacturing for a local drug marketing / franchise company is still restricted.
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How is the new contract manufacturing policy helping the industry to develop?
The new policy allows the importer of already registered medicines to locally develop import substitution through a contract manufacturing agreement with a registered pharmaceutical manufacturer of DRAP and has also facilitated foreign pharmaceutical companies (including licensees regulatory authority of reference such as the United States, Canada, United Kingdom, Australia, EU or Japan) to have their affected products registered in their own name under a Contract manufacturing agreement with pharmaceutical manufacturer registered in Pakistan.
Previously, this was only allowed to foreign pharmaceutical manufacturers. This practice will enable international pharmaceutical marketing companies to invest in Pakistan for the marketing, sales and promotion of their international brands in Pakistan, create employment opportunities and positively contribute to the economy.
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The new policy has further enabled international exporters to have their branded products / generics manufactured in Pakistan without any problems and is likely to encourage pharmaceutical manufacturers in Pakistan to set up FDA / EMA approved pharmaceutical manufacturing. / UKMAHRA / TGA / PICS / WHO facilities in Pakistan; as their risk of not having all dosage forms for a branded molecule / generic will now be mitigated through the facilitation of contract manufacturing agreements with other counterparts.
Pakistani pharmaceutical companies were previously handicapped due to the previous restrictive policy of contract manufacturing, and business opportunities for contract manufacturing of international brands were often lost for pharmaceutical manufacturers in India, China and Bangladesh.
However, with this new policy and the expected synergies in it, it is very likely that Pakistani pharmaceutical manufacturing companies will soon emerge on the global stage as a highly reliable resource for the contract manufacturing of branded generic commercial companies. and international marketing with marketing authorizations throughout the world. .
The Pakistan Pharmaceutical Manufacturers Association (PPMA) expressed gratitude and thanked HE Prime Minister Imran Khan, Razak Daud (Trade and Investment Advisor to Prime Minister Imran Khan) and Dr Faisal Sultan (Special Assistant Prime Minister Imran Khan on National Health Services) for approving and publishing this long-awaited contract manufacturing policy on hold and paving the way for developing synergies and boosting the country’s pharmaceutical exports.
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