Since the Drug Price Control Order of 1970, drug prices have been under government control and successive orders have been issued in 1979, 1987, 1995 and now a draft policy again in 2006.
Whether these orders have been really doing any good to the industry is a big question mark.
Of course with all these hurdles, the industry have become strong in attitude and mind set and carved a niche for themselves in their own country and abroad, thus making the saying true that "when the going gets tough, the tough gets going".
All the orders passed since 1970 have always had put up a front as though the government is helping the common man. However they all had a sinister pattern and political interests in them than helping the industry with strategic plan for growth.
It is some time surprising that the officials have never looked at this industry as one, which had a much bigger scope than the IT industry. Had there been a rational approach, which could have been put in place instead of a prejudiced approach, and perhaps, our industry would have been among the top in the world. An opportunity missed badly and worst part of it is that even today in the draft policy of 2006, one sees nothing progressive but with populist measures. Votes have always had a say in these policies.
Things anyway, would have happened even without a policy after all, but whatever good has happened because of the toughness of industry, the government has always claimed it as their part of success.
The only two beneficial things, which happened over these 36 years, is the Process Patent regime introduced by the government. This enabled our Indian counter parts come to the fore in the domestic and international scenario.
The second point is that the drug prices control order has indeed brought some semblance to the drug prices from runaway pricing by multinationals, who were used to copy their principles of the head quarters in terms of pricing in our country. Other than this, we have only seen that the counter parts in India have always lost out, in the non-lucrative price regimen followed by pricing authorities.
While pricing the products, factual approach is not followed. Thus the prices approved went so bad that, they did not include many possible inputs of inflation and the inventory norms, which are important to manufacturing of quality products. This precipitated into the manufacturers stopping production of essential products and entering into non priced areas.
An adequate amount of funds and time was always a dream for the regulatory authorities to regulate these policies too. When the policies were initiated then, the participants to augment the policies did not include any body from the industry and pharmacy associations. The committees constituted only those who had very little say or were ignorant in the strategic fall out of the policies in the months and years to come.
The only welcome change in the present draft policy 2006 is that the industry involvement was allowed at the last moment after a hue cry of industry associations and also in order to see that, there was a smooth sailing of the policy without any ruffles by accepting some of the provisions to appease the industry.
Through these policies, the government has created an atmosphere of uncertainty and allowed all the members of the industry to be vigilant, and not to get caught in the net or in the wrong side of the Government. Even now DPEA claims and counter claims are still to be settled.
In the above process, many of them have cultivated and acquired habits over the years, of exploring the loopholes in the policy, to wean away from the clutches of the government. It is very apparent today thus; we have products, which are not price controlled, and which brings in profitable revenues to the companies rather than products. These products are absolutely essential in true sense of the patients and the mass population, which suffers.
The later policies issued have only tried to make an attempt to correct these flaws with yet another policy, sending signals that the government has the authority to curb, control and punish and thus, distancing itself from the industry instead of coming closer to the industry. If given an opportunity to the industry and taken them closely and consulted in the major areas of thrust, with a free flow of suggestions of strategies, then the so called team would have evolved a much better health scenario through a rational and functional policy in the country.
Diseases like Malaria, Typhoid, Chikunguniya, T.B and the other viral diseases is visiting our population at regular intervals and we do not have neither any disaster management in these areas nor any specific regimen to be put in place. Every endemic and pandemic situation is being treated empirically rather than in a scientific manner.
Our country has failed in many areas and some of these are so much glaring.
1) Knowing well that globally, we may have to end up on a patent era, we should have taken a bold step then, of allowing the companies to get into R & D through incentives for evolving new NCE. Instead we were happy with the process patent and reverse engineering. Even today in spite of so many announcements in the R & D area there is hardly any monitoring or short listing of companies. They have so many professionals working in NPPA, but hardly any faculty members to assist, encourage and persuade companies to enter into R & D area. A technical faculty personnel or a scientist in the true sense should have been over looking and monitoring. Big question marks are raised when figures appears in the balance sheets of many pioneering companies under the head of R & D.
2) Every type of industry has got rid of the clutches of price control and regulation commercially in this country, except Pharma industry. While we understand that FDA should regulate the drug industry for quality control in manufacturing and falling in line with global standards, why not we allow the industry to have a fair play in the market and allow the market forces to take over in terms of price control in pricing?
Our aviation industry is a clear recent example, where one sees self control in pricing.
One has to admit that there are many flaws, which could be enlisted about Pharma Industry in this country and the government Policies
1 Prejudiced approach of the authority.
2 Punishing attitude of Tax Departments.
3Corrupting influences and environment in the regulatory scenario.
4 Shortage of essential medicines due to unprofitable business sense.
5 Tactical corrective action missing whenever brought to notice of the Industry.
6 Obsession of authorities to control the industry instead of giving the industry a free hand.
7 Failure to see the vision for Indian pharma industry for the future.
8 Diluted approach while evolving a proper health policy.
9 Industry and other associations only used for in puts at the authorities convenience.
10 As a fall out of all these policies, today, the country is with a plethora of formulations, what you call as FDCs (Fixed Dose Combinations), many of them irrational and at prohibitive in costs.
11 Medicines having no patient information leaflet in the packs, which is a mandatory provision, the reason being the price control on products and therefore cost not affordable to accommodate a leaflet inside a pack. A patient is ill informed about the drug he/she is consuming.
12 Not appreciating and envisaging the infrastructure required for small industries to grow and failing to appreciate and to correct theatmosphere through policies which is pro growth oriented.
Finally a failure to stage a true brainstorming among the people who really matter, on the future of the industry through total participants of industry personnel, associations, Pharmacy council etc., thus missing an opportunity to launch the Pharma Industry to garner that extra push in the global arena. Thus we fail to evolve a healthy Pharma Policy in place rather than having the strangulating bureaucratic control. Any number of policies, however common man oriented and populistic and political, will always end up with aberrations unless, there is a total involvement of the Industry per say from all angles. Failure to 'Trust & Prejudices' will always be a deterrent in evolving a practical and genuine method for taking the country to newer heights in the area of Pharmaceuticals, which ironically is with a nomenclature, as a sunshine industry or a star industry.
It is necessary for all the decision and policy makers to have a proactive approach for better days for this know-ledge based industry, with all right people around it.
(The author is SSI sub-committee chairman, IDMA and is part of the LOC for IPC, Mumbai)