Like the legendary beauty queen Cleopatra, age cannot wither nor custom stale the infinite variety of Maharashtra which had lorded over the socio-politico-economic scenario of India. Especially it had made an indelible mark on the pharmaceutical landscape of the nation. Mumbai, the commercial capital of India, like the queens necklace it wears, houses the corporate offices of the movers and shakers of the Indian pharma.
Keeping its legacy as the torch-bearer of the Indian pharma industry, the Maharashtra Government bodies, corporate houses and trade bodies alike are continuing with their untiring efforts which had made the state the numero uno in the pharma horizon of the country.
According to a Pharmabiz study, the Maharashtra- based 50 listed pharmaceutical companies have dominated Indian pharmaceutical sector with over 40 per cent contribution to revenues during 2014-15. Huge investment in domestic and international facilities, mergers & acquisitions, strong R&D base, higher international approvals, focus on innovations, strong presence in highly regulated markets as well as emerging markets, tie-up with multinational companies for clinical trials, contract manufacturing, in-licensing and entry into new therapies assisted the onward march of these companies.
Majority of these companies had rewarded investors with better returns on investments. The 50 companies, with registered office located in Maharashtra, have generated net sales of Rs 70,098 crore during 2014-15 as against Rs 65,958 crore in the previous year, a growth of 6.3 per cent. These companies are focusing on anti-TB, cardiology, central nervous system, diabetes, anti-asthma, COPD, gastro-intestinal, gynaecology, immunology, pain, women's health, neurology & inflammation, infections, metabolics etc.
Aimed at further evolving the pharma manufacturing landscape, the Maharashtra Food and Drug Administration (FDA) besides launching an online Extended Licensing Node (XLN) system for easy and timely access and approval of manufacturing licenses, has a bouquet of other offerings too.
Other unique offerings include WHO GMP certificates in 10 days coupled with regulatory initiatives by the state regulator like enforcement for compliance to Drugs and Cosmetics Act with reference to Schedule H1, compliance towards discouraging irrational usage and overpricing of drugs, action against illegal online pharmacy trade and recommending medical devices like drug eluting stents (DES) to be brought under Drug Price Control Order (DPCO) in the wider interest of the patients which have been lauded by the industry as indicators for growth.
Considering the cases of rampant illegal sale of prescription drugs online through certain e-commerce websites, the Central Government has also formed a sub-committee recently under the chairmanship of Maharashtra FDA chief, Dr Harshadeep Kamble to look into the issues related to it and accordingly frame uniform guidelines or rules to regulate online pharmacy in the larger patient interest. The other members of the committee are Karnataka drugs controller Raghurama Bhandary, along with the drugs controllers from Delhi, Odhisha and joint drugs controller, CDSCO, Dr S Eswara Reddy.
In the wake of information technology advancements, drug being an important segment in the e-commerce space is critical to the growing patient population who are looking for efficiency and convenience in access to medicines in a timely manner. Therefore, online pharmacy was on the top of the agenda of discussions at the 48th Drug Consultative Committee meet this year.
As per the Section 18 (c) of Drugs and Cosmetics Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. Rule 65 prescribes the procedure to be adopted by the medical stores while selling the prescription drugs and under which the prescription from the registered medical practitioner is necessary for sale of Schedule H drugs under the Act.
Action on overpricing stents
Maharashtra drug regulatory agency has also set a precedent by recommending National Pharmaceutical Pricing Authority (NPPA) to bring cardiac stents under National List of Essential Medicines (NLEM). This came to the fore in the wake of reports about cardiac stents being sold at inflated prices following which Maharashtra FDA detected five such distributors involved in overpricing stents. This was the outcome of a probe conducted by Maharashtra FDA over a period of six months.
An inquiry into the rampant malpractice, according to the FDA Commissioner Dr Harshadeep Kamble, has further revealed that cardiac stents were exorbitantly priced across seven hospitals from Mumbai, Pune and Nashik. The MRP of the imported stents are usually jacked up by 300 per cent to 700 per cent of the actual cost of import. This is an exploitative practice and fails to address the concept of patient care, says Dr Kamble.
Inquiry by the Maharashtra FDA revealed that patients were being forced to pay double or even triple the price for cardiac stents at hospitals. As most of these are not available in the open market, patients can't check prices and are held hostage by the hospitals, which force them to buy at the price they quote. However, experts opine that having an MRP has not prevented profiteering in medicines, with the MRP being fixed high enough to accommodate commissions since there is no limit on what the MRP can be.
Medical devices including cardiac stents and DES are notified as drugs under the Drugs and Cosmetics Act, 1940 but is not included under the Drug Price Control Order (DPCO-2013). Therefore, the prices of medical devices cannot be monitored and controlled as of today. The FDA has therefore urged NPPA to bring coronary stents under the ambit of NLEM to control its prices.
Further compounding the problem is that the MRP of a drug eluting stent is fixed by the importing company. As the manufacturers of these devices are located overseas, it is difficult to study the manufacturing cost and export prices of these devices. Besides this, the startling fact is that the cost of DES is immediately recovered from the patients but payments to the distributors are made after a period of 60 to 120 days. The payments of applicable taxes of the concerned sale transactions, to the state government are made only within 51 days by the distributors.
Enforcing compliance to rules
Against the backdrop of over 15 raids conducted till date on the illegal sale of habit forming drugs like cough syrups containing codeine phosphate, Maharashtra FDA has alerted pharma companies like Pfizer, Cipla and Lupin to keep a tab on the distribution channels to address its illegal sale to drug addicts. Cipla and Lupin has, however, stopped producing codeine containing brands like Rexcof and R-coff respectively following its irrational use, according to an FDA official.
According to official sources, Maharashtra FDA has asked the concerned companies to plug the loopholes in the distribution channel as codeine phosphate containing syrups have been sold in a clandestine manner involving smaller drug dealers.
Maharashtra FDA has in total detected 25 cases of illegal sale of codeine containing cough syrups by unauthorised persons to drug addicts without a prescription. As per official reports, FDA has been monitoring rampant misuse and abuse of cough syrup brands over the past one and a half years. It has also been observed that stockists have been found violating the conditions of licence.
FDA officials maintain that FDA has been successful in curbing such illegal activities. Action has been taken against the offenders as per Rule 65 of the Drugs and Cosmetics Rules in contravention to the conditions of licence. According to the Maharashtra FDA report on 'abuse of codeine containing cough syrups', it has been observed that figures of some of the leading brands are not proportional to the population figures and varies from state to state.
As a part of its drive to ensure compliance to the conditions of licence as stipulated under Rule 65 of the Drugs and Cosmetics Rules, 1945, the Maharashtra FDA has taken action against a number of wholesalers in Mumbai and Thane. As per officials, show cause notices were also served to the wholesalers for their explanations in these cases.
FDA has intensified the crackdown on the errant wholesalers considering the fact that cases unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant. Stockists were being inspected for compliance to schedule 65 of Drugs and Cosmetics (D&C) Act, 1940 and Schedule 5 of Drug Price Control Order (DPCO) - 2013.
Upgrading drug testing infrastructure
In order to make drug recall faster and more effective, the Maharashtra FDA is in the process of upgrading the drug testing infrastructure in the state. This would help in considerable reduction in downtime with samples being tested in a mere three days time as compared to three months earlier.
Says a senior FDA official, "Drawing drug samples, analysing them for safety and drug recall will get a boost with the upgradation of drug testing infrastructure. This will make the information on substandard and not-of- standard drugs reach the patients and chemists at the very moment it is analysed and tested. Drug recall is a very arduous task as it has been realised that not-of-standard drugs remain in the market for 62 days on an average before it is consumed by the patient. Timely analysis and effective drug recall is therefore the need of the hour."
Ayurvedic clusters
To bring in standardization for small ayurvedic manufacturers and to help them grow their manufacturing businesses, the Ayush department has set up two clusters in Maharashtra namely 'Konkan Cluster' and MAC- Pune Cluster to facilitate the licensed manufacturers get more common facilities through the cluster approach. The Konkan Cluster has been set up under the company - Konkan Ayur Pharma Pvt Ltd.
The second ayurveda industry cluster Maharashtra Ayurved Centre Pvt Ltd. (MAC) under the Centre's Ayush scheme has been developed at Kolewadi of Pune district.
The approach of the cluster to involve 35 to 40 manufacturers ensures a common facility for around 15 different sections like tablets, capsules, powder, syrup etc but would also offer advanced lab testing facilities under one roof thereby enhancing efficiency, authenticity and efficacy of the product.
Speaking about the success of MAC - Pune cluster, Dr Sunita Belgamwar, chairperson of MAC explains, "The cluster has given us an opportunity to develop a 360 degree horizontal model to propagate concepts and principles of Ayurveda to the farmers, traders, doctors, researchers, pharmacists and other stakeholders through interventions like exhibition, new drug and process design for mass production, contract manufacturing, raw material processing and sale, quality control lab and entrepreneurship development centre."