Drug Controller General of India (DCGI) have banned raw material import from 10 Chinese drug companies for supplying materials without having the mandatory drug manufacturing standards. They cancelled the registration of these companies last week, making it impossible for these companies to import products manufactured by them into India. According to industry official, DCGI found during inspection that the Chinese companies had not submitted proper good manufacturing practices (GMP) certificates which lead to the cancellation of their licenses to import products into India.

India imports active pharmaceutical ingredients (API’s) mainly from China. Indian drug companies use these API’s and other intermediates to manufacture the drugs which are sold in the domestic and international market. Some of the raw materials which were banned include clotrimazole, mefenamic acid and sulphadoxine that are used to make anti-infective and painkillers.

Indian drug companies were concerned that a single lapse in manufacturing standard can result in cancellation of their exports by foreign drug makers as India exports medicines worth Rs. 42,000 crore every year while another Rs.58, 000 crore are sold in the domestic market. A senior health ministry official said, “We have to ensure that drugs made here are of top quality, if we are to become the pharmacy of the world in the next decade or so”

An industry executive quoted that as limited Chinese companies supply these ingredients, there might be shortage of these drugs in the domestic market. However, according to Lalit Kumar Jain, chairman at SMPIC, an association of small drug makers said, “This will give a chance to local API companies to increase sales.”

Anti-smoking market in India is estimated to be around Rs. 720 crore. Many doctors are prescribing drugs to help patients get rid of the habit. Awareness about tobacco-related cancer has also prompted many people to take up anti-smoking pills. Elder Pharma plans to enter the nicotine replacement therapy, or anti-smoking segment, with chewable jelly cubes. These chewable jelly cubes reproduces the sensation of tobacco chewing while providing nicotine to addicts. Other companies which are already present in the anti-smoking segment are
Sun Pharmaceuticals, Pfizer, Cipla and GSK. These companies have products either in the form of trans dermal patches, chewing gums, inhalers, nasal sprays or lozenges.

The current market for prescription drugs is around Rs.200 crore, the remaining sales are from the over-the-counter products. According to Alok Saxena, director of Elder Pharma, the company is planning a revenue of around Rs.18 to 20 crore from this product in three years. The operating margin on the product is likely to be between 18-20 percent, he added. The company’s revenue is Rs 702.4 crore in the year ended March 2010, with earnings before interest tax, depreciation and amortisation, or EBITDA, at Rs 109 crore and net profit of Rs 55.3 crore.

Elder Pharma has signed an agreement with Gelnova Laboratories to manufacture the product as they do not have the technology to make the product in the gel form. The product will be launched in 3 strengths- 1mg, 2mg and 4 mg and in two flavors mint and pan masala. It is designed to last for around 30 to 40 minutes in the mouth.

By 2020 India will join the top 10 global pharmaceutical market. According to a report by PricewaterhouseCoopers (PwC), India’s pharmaceutical sales will reach USD 50 billion by 2020 enabling it to reach the top 10 global pharmaceutical market. Pharmaceutical market in India is driven by growing ageing population and improving economy. A large section of middle-class population who can afford western medicines and ageing population with cardio-vascular and central nervous system disorders is driving the pharmaceutical market. India’s competency in terms of knowledge and manufacturing expertise has made it a sought after country for contract manufacturing. Around USD 70 billion worth of drugs are expected to go off patent in the US over the next three years. It’s estimated that India will manufacture a major share of these patented medicines.

Currently India produces more than 20 percent of the world’s generics. According to Sujay Shetty of PWC, “Global players in the pharmaceutical industry are seeing immense prospects in the Indian market due to its sheer demographic profile. India could be the most populous country in the world by 2050 and is now making its mark as a growing market”. He further said that, “Several Indian firms have already entered into research partnerships with multinationals–Dr Reddy’s Laboratories Torrent has joined hands with Novartis while Ranbaxy has formed alliances with GSK and Schwarz Pharmaceuticals”. Adding to the manufacturing expertise, India has the largest pool of English speaking population which has enabled it as a source for talent for research professionals.

After inaugurating three generic medicine stores in Bhubaneswar, Union Minster of State for Chemicals and Fertilisers Srikanta Jena, said that India ranks first in exporting generic medicines worth Rs.50, 000 crore per year. The quality of the medicines is maintained by the Indian Drugs and Pharmaceuticals Limited. While addressing the launch, Jena said, “Orissa was the fifth state in the country and first in eastern India to have launched ‘Jan Ausadhi Abhiyan’, the national campaign to ensure universal reach of generic medicines”.

He also said that generic stores would be opened in all 626 district headquarters hospitals in the country. And an amount of Rs.2.5 lakh will be given as one-time assistance for buying the medicines. Punjab and Rajasthan has made good progress in inaugurating such stores, as they have around 30 stores till date.