‘Initiate stringent measures to improve quality of medicines’

“Khali Haath Aaya Hai, Khali Haath Jayega, the manufacturers, traders, doctors, regulators and many persons involved in Pharmaceutical business in India should remember this quote. It’s a high time to play with common people in the name of affordable health care and cheap medicines in India,” said Dr Prem R Goel, Pharmaceutical Consultant, QMS System and Data Integrity Specialist. A stalwart of Pharmaceutical Industry who travelled across the world and offering his expertise to number of pharmaceutical companies across the world, Dr Goel was in city to participate in Dr A.K Dorle memorial lecture series organized by Alumni Association of University Department of Pharmaceutical Sciences (UDPS) on Monday. Talking to The Hitavada about the present trends in Pharmaceutical Industry in India, Dr Goel stated, “The country has become a dumping ground for many irrational drug combinations, unwanted drug molecules and useless diagnostic procedures.” “There are more than 25,000 manufacturing units in India. These units include, multinationals, big pharmaceutical companies, medium and small scale industries. There are more than 8 lakh chemists involved in pharmaceutical trade across the country. They include retailers, wholesalers, stockiest, carry and forwarding agents etc. As far as regulatory affair is concerned, the country has very weak regulatory affair.

There are number of licences and tedious procedures to get these licences. The manufacturing and sale licence as per Drugs and Cosmetic Act, GMP Act, WHO act etc. No one in India talks about or considers the value of quality and standards of medicines manufactured or sold in India,” he added. Dr Goel belongs to New Delhi. He completed graduation in Pharmaceutical Sciences (B Pharm) from University Department of Pharmaceutical Sciences, Nagpur University in 1973. After completing graduation, he completed M.S. in Pharmaceutical Sciences and PhD in USA. He worked with Pharmacia, a leading multinational in USA till 1985. He also worked in UK for two years in GlaxoSmithKline (GSK), two years in Germany in Merck and 12 years in China for a multinational company. After having 28 years of experience in Pharmaceutical Industry at different levels, he started working as a consultant for USFDA across the world and visited number of countries. When the entire country has started promoting Generic drugs and batting for cheap drugs, Dr Goel mentioned, “Whether the drug is branded or generic, emphasis should be given to quality and standard of the drug. Generic is not a new concept. This concept was promoted in USA about 20 years ago.

Many pharmaceutical companies in USA and UK are manufacturing both branded as well as generic drugs. But they never compromise on the quality and standards of the drugs. These countries have strong regulatory procedures, no corruption and utmost importance given to health care of common people. This is the reason, there are number of drug or food recalls, convictions, imposing of fines etc are seen in these countries. I have not seen any food or drug recall by FDA or Central Drug Controller in India after getting the report about substandard or spurious drug declared by public analyst.” Talking about the quality and standard of active pharmaceutical ingredients (API) and their intermediates from imported from China, Dr Goel agreed, “China has taken a lead in manufacturing API and their ingredients. The pharmaceutical industry in China has grown well. Even the countries like USA and UK are purchasing the API from China. These countries are following strict vigil and vendor evolution procedure, but India is not following the same. There is a difference in mentality of Indian manufacturer and that of USA or UK. Indian Manufacturer starts bargaining for the cheap API while the manufacturer from USA and UK never compromises with the quality of API. China is exporting API to all countries to earn money in shape of dollars and building its economy.

Indians are finding it very difficult to export the Generic medicines manufactured with API from China. This is the reason, Indian FDA should be more vigilant, stronger and Government should encourage the Pharmaceutical Industries by simplifying the procedures.” It is also surprising to see Indian companies are manufacturing and selling Generic Medicines with their own brands. This is not the case with companies in USA and UK. Here, in India, even the multinational companies are manufacturing their ‘branded’ products from small or medium scale companies having GMP or WHO licence. To earn, huge profit margin, the companies have floated number of brands of same generic products; the syndicates of doctors, chemists and industries are busy in manufacturing number of brands. The companies should cut down their brands, stick to manufacture generic, he added. Expressing a concern over failure of WHO GMP licence process in India, Dr Goel stated, “To strengthen the Indian Pharmaceutical Industry, Government should encourage ‘make in India and made in India’ scheme. Licence Raj should be curtailed. The regulatory affair should make accountable. Government should follow The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) which is an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.”